The Senior Analyst is part of the Quality Control (QC) department of STA Pharmaceuticals Switzerland. He/She is responsible for executing protocols for method validations, verifications and transfers for the QC Laboratory. The position will also perform all testing of both material and finished product in support of the larger product introduction activities e.g. testing of samples for stability registration studies, process validation or cleaning validation. Additional duties includes participation to investigations in case of deviations, cleaning validation, preliminary testing, and preparation or review of documentation As a QC Team Member, the person filling this position supports all activities to continuously maintain the GMP status of the QC Laboratory. As a Senior QC Team Member, this position acts as a center of competence reflecting experience, transferring knowledge and supporting other QC team members in all aspects of their daily work.
Performs analytical testing of raw material, in process, finished products samples in support of product introduction activities. Execute methods as HPLC, GC, UVNIS, IR, dissolution, pH, conductivity, TOC, titration, weighing etc Performs review of analytical data. Execute protocols, methods, and procedures with adherence to cGMP documentation requirements. Writes or reviews all types of GMP documents (e.g. test method, SOP, WPR, validation protocols and reports, investigation reports etc.) Handles deviations and OOS in the applicable software tool Handles change control in the applicable software tool Supports internal and external audits Takes responsibility in method transfer and method validation activities. Takes responsibility in selection, purchase and commissioning of new equipment. QC representative in transversal project. In charge of the support of QC team members ("center of competencies") Performs basic laboratory work (buffer preparation, waste disposal management, washing of lab dishes, cleaning of the labs etc.) Supports maintenance/calibration of equipment and keeps relationship with suppliers. Can support commercial or other activities in QC May be assigned special duties and tasks (e.g. responsibilities for EHS, LIMS, computerized systems ) EHS This position is responsible to ensure all EHS requirements in the laboratory. Respect EHS procedure and rules Report immediately all incidents and near-misses to the management and/or to the EHS representative people
Experience / Education Federal Certificate of Capacity as Laboratory Technician or similar education 4-5 years of work experience in a GMP environment Experience of doing analytical testing according to Ph. Eur. and USP prescriptions. Knowledge / Skills / Abilities: Excellent knowledge in HPLC and GC techniques and CDS Excellent knowledge of dissolution, UV/VIS and IR techniques. Knowledge of analytical method transfer and analytical method validation. Very good communication skills Very good writing skills. Excellent team spirit. Very good knowledge in English and French. Very good knowledge of most common office software and capability of handling more complex lab software (e.g. LIMS) Capability for know-how transfer to and training of other QC team members.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
The MS&T Senior Engineer is in accountable for the new introduction of oral solid dosage forms (capsules and tablets) at our Couvet, Switzerland site. T he MS&T Senior Engineer, authors, leads and updates of Technical Transfer Plan and Gap analysis. He/she trains the operational teams to the protocol/master batch record for the new product. He/She acts as a role model and mentor for less experienced colleagues.
Functions: Lead risk assessments and risk management cross functional teams (from draft to approval). Lead projects and initiatives as directed by client, to be completed autonomously using the project management tools and approach. Accountable and responsible for Tech Transfer and Gap Analyse and follow up approval flow within electronic documentations system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner internally and with the client. Accountable through developing the technical transfer plan and gap analysis of new products in collaboration with bulk, packaging, NPI QC and quality departments. Responsible as a SME for manufacturing topics with customers for the assigned project. Is the key contact for manufacturing topics related to new product introduction (collect the input from operational team, provide feedback/input to the NPI management). Support : Support in alignment with QA and for QA the Critical Quality Attributes and Critical Process Parameters definition and implementation. Act as quality system and GMP Documentation support for the manufacturing Ops team Support the manufacturing and packaging activities related to the new product introduction on-the-floor with the production team if necessary. Support the Initiation of deviations by the production compliance officer and participate in the floor investigations, if needed. Partner with QA and Packaging or Bulk Operations to ensure assessments and investigations are exhaustive. Contribute actively to continuous improvement initiatives, including proactively identifying problems, gathering input from the operational team and proposing solutions. Establish clear improvement plans Follow-up: Follow up and implement assigned CAPA's. Follow up approval flow within electronic documentations system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner.
Experience / Education BS/MS in Engineering/Technical discipline or equivalent experience 10 - 15 years' experience in pharmaceutical industry with a proven track record on New Product Introduction, solid dosage forms and validation Knowledge / Skills / Abilities: Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes. Well-developed ability to constructively work across functional teams to achieve results, Strong verbal and written communication skills, Strong analytical, problem-solving skills, Communicate positively and in a winning and persuasive manner Capability to work with short deadlines and simultaneous activities, Excellent organizational and project management skills, Fluent in English and in French. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
This position is accountable for the Quality Control activities at the OSD drug product manufacturing site of Couvet, Switzerland, including method transfer / verification, the analytical & microbiological testing of incoming materials, packaging components, in-process testing, drug product & drug substance release testing and stability testing, as well as equipment cleaning residual testing and support the manufacturing related area operation such as environment monitoring. You will ensure activities meet cGMP requirements and customers' expectations. As the QC leader, you will be focused on the customers' needs. You will mentor and coach your team, creating a strong team spirit. Using your significant experience, you will streamline QC processes and implement efficiencies. This position is a strategic leadership role for the site and a role model for WuXi values and competencies.
Essential Job Functions: Responsible for the project management to ensure on-time and high-quality execution of analytical activities, including method transfer / verification and all testing, in compliance with the site's Quality Management Systems (QMS) & cGMPs. Accountable for meeting customers' expectations and needs. Responsible for leading OOX results laboratory investigation and deviation investigation, perform impact assessment and establish corrective actions & preventive actions (CAPA) based on the root causes. Responsible for reviewing and approving quality events (deviations, CAPA actions, OOX, CCR ). Accountable for optimizing QC processes, including procedures and daily operations to reduce lab errors and increase efficiency. Accountable for overviewing the daily management of the Quality Control team (planning, communication, team organization, control & feedback). Represent QC during client visits, audit and regulatory inspections as well as health authority audits. Responsible for QC medium- and long- term equipment and personnel planning Accountable for ensuring staff have adequate training to perform activities By collecting information and understanding facts to identify issues in the lab, draw correct and valid conclusions. Apply risk management tools to make decisions . Responsible for QC team talent development, including succession planning and career development. Be able to effectively oversee analytical processes based on production schedule. Responsible for budget of the QC laboratory. Act as a backup for the commercial release activities (paper or within the LIMS).
Experience / Education University studies in chemistry, biochemistry, biology, or pharmacy or equivalent. >10 years' experience in QC laboratory management, CMO advantageous Knowledge / Skills / Abilities: Fluent in French and English. Autonomous and aptitude to work on the ground. Solid knowledge of analytical technologies and laboratory workflows, such as HPLC, dissolution, Karl-Fischer analysis, etc. Knowledge of electronic data lifecycle management in the laboratory to ensure data reliability and integrity. Familiar with method transfer and validation of drug products, material and product release as well as stability studies of drugs under different conditions. Familiar with laboratory investigation and establishment of corrective and preventive measures. Strong working knowledge to ensure quality control compliance with applicable regulations i.e. cGMP. Organized and rigorous, able to provide leadership and coaching to the QC team in order to maintain an environment of trust and personal accountability. Demonstrate ability to effectively communicate with the team and all levels of the organization. Work as a strong team partner in the site. Use of scientific risk assessment based on sufficient data to reduce and control the risk of late-stage commercialization project operations. Ability to make decision. Able to manage, track and record budget.
Job Summary: The Validation Technician, Validation Operation Services performs validation and qualification activities. They assure compliance of these activities with cGMP as well as with internal policies and procedures. The Validation Technician is authorized to direct external vendors performing work in this field.
Essential Job Functions: Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle. Author and when required review qualification and validation documentation, including risk assessments, specification documentation, validation plans, protocols, reports, traceability matrix and summary reports Execute qualifications for all equipment and systems across the site, including QC, production, warehouse, facilities, equipment, utilities and computer system validation, excluding global IT systems. Execute validations for all processes across the site, including cleaning processes, bulk process, packaging processes and warehouse / sampling processes. Participate to the development and maintenance of the local site procedures Participate to risk assessments and risk management teams Review change controls / NEF documents to evaluate impact on qualified systems and validated processes Develop and justify the validation approach based on risk and a scientific rational Co-ordinate qualification and validation execution activities, including external vendors and internal departments
Experience / Education BS in Engineering or Technical discipline. Experienced in pharmaceutical qualification and validation; at a solid dosage plant is advantageous Knowledge / Skills / Abilities: Familiarity with current international regulatory regulations, cGxP requirements and best practises, including 21 CFR part 11, 210 and 211, Annex 11n, EU-GMP guidelines and GAMP Good communication skills in English with facility, production, laboratory, technical operations, QA, and outside vendor groups; French advantageous Team player: ability to interact effectively with team and customers
Le Technicien Packaging aura pour mission de supporter les activites de conditionnement dans le respect de la reglementation cGMPs , des regles d'hygiene et de securite. II devra se conformer aux procedures definies par le systeme qualite du site pharmaceutique.
Mise a jour et creation de documents techniques necessaires au fonctionnement des equipements et de la ligne (instruction d'utilisation, de nettoyage ). Maitrise Ia conduite de lignes de packaging automatisees. Support technique pour ses collegues et joue un role de formateur pour les nouveaux collaborateurs. Maitrise et effectue le nettoyage des equipements et petits materiels lies a ces differentes stapes. Assure le maintien des zones sous sa responsabilite (i.e. nettoyage de la salle, rangement, disponibilite des outils necessaires, disponibilite des consommables et EPI) Effectue les changements de format, reglages de base et le vide de ligne production. Se conforme aux directives et instructions definies dans le systeme qualite de notre site pharmaceutique. Aptitude a se conformer aux objectifs de production et respect du planning etabli. Assure Ia realisation des operations de conditionnement des lots industriels en environnement GMP et travaille de fawn autonome et efficace selon les consignes de son responsable. Contrale, enregistre et completer les documents de travail pre-etablis pour assurer un suivi des operations realisees (dossier de lots remplis selon les GMP). ContrOle de la conformite des matieres premieres et ou articles de conditionnement utilises sur les lignes. ContrOle physique elementaire des produits conditionnes. Participation a la validation des procedes industriels. Fabrication des lots de validation. Genere une demande d'intervention de maintenance en cas de panne equipement et assure son suivi jusqu'a la reprise de la production. Sait resoudre des pannes equipements et supporte la maintenance en cas d'intervention. Rediger I'ouverture d'une deviation et communiquer avec le service Quante. Mise en place d'un change control et suivi des etapes du plan d'action. Maitrise de I'ERP et de ses modules complementaires Creation de recettes pour parametrer un equipement sous la supervision de son responsable.
Experience / Education Avoir une formation initiale de niveau CFC de laborantin, ou une experience de 3 ans dans le domaine de I'industrie pharmaceutique ou equivalente. Knowledge / Skills / Abilities: Connaitre l'environnement GMP et/ou l'environnement de travail en salle blanche. Avoir une parfaite maitrise du francais. Polyvalent, organise et rigoureux, avec de grandes qualites relationnelles pour un travail d'equipe. Bonne communication avec les services support. Esprit critique et est force de proposition dans un but d'amelioration continue. Connaissances des outils informatiques de base (Word, Excel)
The Senior Manager QA Project is responsible to support the entire Couvet site to ensure that each product is continuously manufactured, packaged, and tested in compliance with the Marketing Authorisation Dossier managed by the Customer/Product Owner and also to represent the site in the Company Regulatory Surveillance initiatives.
As a member of the Quality Leadership Team, the position holder is collaborating with the other members of the QLT to ensure that on the Couvet site the Quality Systems are maintained and improved and that any cGMP compliance issues is duly addressed in a timely manner.
Essential Job Functions: Act as the deputy of the Responsible Person (RP) according to Art. 5, and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR 812.212.1) and of the Qualified Person according to Annex 16 of the EU Guide to Good Manufacturing Practice for Couvet site. Act within the site's key projects teams as the main Quality Operations representative and single point of contact for QA, QC, Compliance and Quality Supplier. Contact with the client regarding quality topics, coordinates response/notification to the client related to quality topics. Coordinate and drive quality activities related to: Technology tech transfer, Raw materials introduction, Supplier qualification, Manufacturing specifications, Conduct assessment of change controls for site-related projects and/or for product life-cycle projects with relevant quality SMEs and act as the site interface with Global Regulatory (CMC & Affairs). Executes and follows up internal/external audits. Actively support site Quality activities such as : multi sites investigations, drive change controls upon requests, internal audits (as auditor) quality complaints health authority inspections continuous improvement Ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility Works closely with EHS to evaluate hazards and perform risk analysis Promotes safe practices and behaviors, verify that EHS rules are implemented and followed Deputy role for and deputy activities
The position acts as deputy of the Site RP for the following quality processes activities under his/her responsibility. Release of batches as RP deputy Close out of Critical Complaints Approval of Complaints Extension Requests when an escalated approval is required. Approval of Investigation Reports/Notifications sent to Health Authorities related to Complaints Approval of documentations related to Suppliers/CSPs qualification and maintenance activities APR/PQR approval
Experience / Education At least 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affair in a pharmaceutical company or other related industry. Bachelor's degree in Pharmacy, Chemistry, Microbiology or related science. Knowledge / Skills / Abilities: Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements. Demonstrated experience in Regulatory strategies and tactics. Strong knowledge of all phases from the global drug development process and clinical trial data flow up to analytical/technology transfer to manufacturing/testing site and product launches. Solid understanding of Oral Solid Dosage form manufacturing, packaging, testing, warehousing processes, validation, and registration. Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation. Ability to transfer strategies to tactical execution. Excellent interpersonal, collaborative and organizational skills. Strong communication skills. Ability to communicate effectively to management, functional groups, broader organization, and executives. High credibility and reliability. Excellent investigational and QA problem solving skills. Ability to interpret complex situations with degree of independence and to articulate recommendations for resolution. Drives continuous improvement. Knowledge of most common office software and of IT-principles. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
Overview The Senior Manager QA Project is responsible to support the entire Couvet site to ensure that each product is continuously manufactured, packaged, and tested in compliance with the Marketing Authorisation Dossier managed by the Customer/Product Owner and also to represent the site in the Company Regulatory Surveillance initiatives. As a member of the Quality Leadership Team, the position holder is collaborating with the other members of the QLT to ensure that on the Couvet site the Quality Systems are maintained and improved and that any cGMP compliance issues is duly addressed in a timely manner. ResponsibilitiesEssential Job Functions: Act as the deputy of the Responsible Person (RP) according to Art. 5, and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR 812.212.1) and of the Qualified Person according to Annex 16 of the EU Guide to Good Manufacturing Practice for Couvet site. Act within the site's key projects teams as the main Quality Operations representative and single point of contact for QA, QC, Compliance and Quality Supplier. Contact with the client regarding quality topics, coordinates response/notification to the client related to quality topics. Coordinate and drive quality activities related to: Technology tech transfer, Raw materials introduction, Supplier qualification, Manufacturing specifications, Conduct assessment of change controls for site-related projects and/or for product life-cycle projects with relevant quality SMEs and act as the site interface with Global Regulatory (CMC & Affairs). Executes and follows up internal/external audits. Actively support site Quality activities such as : multi sites investigations, drive change controls upon requests, internal audits (as auditor) quality complaints health authority inspections continuous improvement Ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility Works closely with EHS to evaluate hazards and perform risk analysis Promotes safe practices and behaviors, verify that EHS rules are implemented and followed Deputy role for and deputy activities The position acts as deputy of the Site RP for the following quality processes activities under his/her responsibility. Release of batches as RP deputy Close out of Critical Complaints Approval of Complaints Extension Requests when an escalated approval is required. Approval of Investigation Reports/Notifications sent to Health Authorities related to Complaints Approval of documentations related to Suppliers/CSPs qualification and maintenance activities APR/PQR approval QualificationsExperience / Education At least 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affair in a pharmaceutical company or other related industry. Bachelor's degree in Pharmacy, Chemistry, Microbiology or related science. Knowledge / Skills / Abilities: Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements. Demonstrated experience in Regulatory strategies and tactics. Strong knowledge of all phases from the global drug development process and clinical trial data flow up to analytical/technology transfer to manufacturing/testing site and product launches. Solid understanding of Oral Solid Dosage form manufacturing, packaging, testing, warehousing processes, validation, and registration. Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation. Ability to transfer strategies to tactical execution. Excellent interpersonal, collaborative and organizational skills. Strong communication skills. Ability to communicate effectively to management, functional groups, broader organization, and executives. High credibility and reliability. Excellent investigational and QA problem solving skills. Ability to interpret complex situations with degree of independence and to articulate recommendations for resolution. Drives continuous improvement. Knowledge of most common office software and of IT-principles. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management. #J-18808-Ljbffr
Overview Le Technicien Packaging aura pour mission de supporter les activités de conditionnement dans le respect de la réglementation cGMPs*, des règles d'hygiène et de sécurité. Il devra se conformer aux procédures définies par le système qualité du site pharmaceutique. Responsibilities Mise à jour et création de documents techniques nécessaires au fonctionnement des équipements et de la ligne (instruction d'utilisation, de nettoyage...). Maitrise de la conduite de lignes de packaging automatisées. Support technique pour ses collègues et joue un rôle de formateur pour les nouveaux collaborateurs. Maitrise et effectue le nettoyage des équipements et petits matériels liés à ces différentes étapes. Assure le maintien des zones sous sa responsabilité (i.e. nettoyage de la salle, rangement, disponibilité des outils nécessaires, disponibilité des consommables et EPI ). Effectue les changements de format, réglages de base et le vide de ligne de production. Se conforme aux directives et instructions définies dans le système qualité de notre site pharmaceutique. Aptitude à se conformer aux objectifs de production et au respect du planning établi. Assure la réalisation des opérations de conditionnement des lots industriels en environnement GMP et travaille de façon autonome et efficace selon les consignes de son responsable. Contrôle, enregistre et complète les documents de travail préétablis pour assurer un suivi des opérations réalisées (dossier de lots remplis selon les GMP). Contrôle de la conformité des matières premières et/ou articles de conditionnement utilisés sur les lignes. Contrôle physique élémentaire des produits conditionnés. Participation à la validation des procédés industriels. Fabrication des lots de validation. Génère une demande d'intervention de maintenance en cas de panne équipement et assure son suivi jusqu'à la reprise de la production. Sait résoudre des pannes équipements et supporte la maintenance en cas d'intervention. Rédiger l'ouverture d'une déviation et communiquer avec le service Qualité. Mise en place d'un change control et suivi des étapes du plan d'action. Maitrise de l'ERP et de ses modules complémentaires. Création de recettes pour paramétrer un équipement sous la supervision de son responsable. Qualifications Experience / Education Avoir une formation initiale de niveau CFC de laborantin, ou une expérience de 3 ans dans le domaine de l'industrie pharmaceutique ou équivalente. Knowledge / Skills / Abilities: Connaître l'environnement GMP et/ou l'environnement de travail en salle blanche. Avoir une parfaite maîtrise du français. Polyvalent, organisé et rigoureux, avec de grandes qualités relationnelles pour un travail d'équipe. Bonne communication avec les services support. Esprit critique et être force de proposition dans un but d'amélioration continue. Connaissances des outils informatiques de base (Word, Excel). #J-18808-Ljbffr
Overview The Engineer, Manufacturing Compliance authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required. He/she supports the Head of Bulk and/or Packaging Operations in monitoring quality and performance metrics and acts as a referee for the operational team for GMP systems, documentation and training. He/she is the manufacturing referee for the batch record creation and revision in PAS-X electronic system. Responsibilities Initiate deviations and participate to or lead on the floor investigations. Partner with QA and Packaging or Bulk Operations to ensure assessments and investigations are exhaustive. Follow up and implement assigned CAPA's. Author and review manufacturing (bulk/packaging) documents, including specifications, working practices, forms, and logbooks. Follow up approval flow within electronic documentation system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner. Lead risk assessments and risk management cross-functional teams (from draft to approval). Act as manufacturing referee for the batch record creation and revision in PAS-X electronic system: provide the manufacturing input, perform the required testing and manufacturing execution to support batch record testing and qualification. Review and approve the batch record and associated Parameters value list (PVL) in PAS-X system. Perform complaint investigations linked to Manufacturing. Initiate, own, and follow up change controls related to manufacturing (bulk/packaging). Manage stakeholders involved. Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions. Participate to or lead projects and initiatives as directed by the Head of Manufacturing (bulk/packaging Operations). Act as quality system and GMP documentation referee for the manufacturing (bulk/packaging Ops Team) and as a key Bulk/Packaging team representative for QA Ops. Support the Head of Packaging Operations in proactively monitoring quality and performance metrics and in proposing improvement measures. Qualifications Experience / Education BS/MS in Engineering/Technical discipline or equivalent experience 8 years' experience in pharmaceutical validation, packaging or related field Knowledge / Skills / Abilities: Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP. Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.). Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes. Well-developed ability to constructively work across functional areas and levels to achieve results. Strong verbal and written communication skills. Strong analytical, problem-solving, influential, and deductive skills. Capability to work with short deadlines and simultaneous activities. Excellent organizational and project management skills. Successful experience in direct people management. Fluent in French and English. #J-18808-Ljbffr
Overview Job Summary: In this position, the Specialist, Manufacturing Scheduling will manage the logistical activity for the manufacturing sites he/she is responsible for within a short and mid-term scope. This mission will be led in close collaboration with the internal stakeholders. The Specialist, Manufacturing Scheduling can act as a back-up for his/her peer. Responsibilities Essential Job Functions: Translate Supply plans into a detailed scheduled plan on a daily basis within the frozen period. Manage the detail scheduling for assigned work-centers and follow up on executions, including non-routine requests. Prepare and lead the weekly scheduling meeting. Define with all stakeholders the action plan for downtime. Follow up on daily operations with all stakeholders (QA, QC, Validation, Production, Warehouse, Supply Chain, etc.). Track Work Orders from their creation to their release. Manage priorities based on business requirements and constraints with stakeholders. Define and guarantee the execution of mid-term plans, including availability of materials and Master data set-ups. Coordinate with stakeholders on the stability plan execution. Coordinate with stakeholders on all variations and support the transition to success. Act as the key point of contact to coordinate make-to-order (MTO) repacking activity. Manage the reprocess activity with stakeholders if required. Accountable for KPIs (On Time in Full (OTIF), Schedule Adherence (TRP), Right First Time (RFT), etc.). Challenge the status quo. Actively participate in continuous improvement activities with other Departments. Accountable for all assigned change control tasks and implementation due dates. Qualifications Experience / Education: Bachelor's degree in Business or Supply Chain with at least 3 years of experience in Supply Chain (production or supply planning). Prior experience within an international industrial environment, preferably in pharmaceuticals or biotechnologies. Knowledge / Skills / Abilities: Strong levels of resilience, able to work under pressure autonomously, with a drive for results and quality orientation; pro-active personality with an eye for anticipation and striving for continuous improvement. Independent self-starter, able to work autonomously. Quick process understanding, insight and visualization, strong analytical and problem-solving skills. Prior experience with LEAN management is an asset. Excellent IT proficiency: MS Office, Excel, ERP; Oracle experience is an asset. Fluency in both French and English is mandatory. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. #J-18808-Ljbffr
