Quality Assurance Specialist - Manufacturing - Permanent position - 100%

Reconnue et incontournable depuis plus de 40 ans, Multi Personnel est une agence spécialisée dans la mise à disposition de personnel administratif et de cadres, temporaire et fixe, dans de nombreux secteurs économiques.

Responsibilities :

• Ensure that activities related to the production quality are conform with the company policies and Corporate Quality directives.
• Main contact in case of production deviation.
• Lead and manage deviations, including those related to production, maintenance, packaging, and laboratory activities, by driving and coordinating investigations in collaboration with the relevant functions.
• Define, implement, and follow up on corrective and preventive actions (CAPA) within the scope of responsibility, ensuring timely execution and effectiveness in line with defined deadlines.
• Manage complaints investigation.
• Participate to the review and approval of the validation/qualification documentation related to production area.
• Ensure the creation, review, and timely update of QA Operations documents.
• Review/approve for issuance of GMP documents related to production area (SOP’s, specifications protocols, reports..).
• Participate in and/or lead risk analyses, in collaboration with cross-functional teams.
• Participate to change control process.
• Auditor in self-inspections and external audits (lead auditor if qualified).
• Support external audit, notified Bodies and Regulatory Authorities.
• Audit trail review of GMP systems.
• Training for classified area.
• Review production batch records.
• Release incoming consumables.
• Review packaging batch records.
• Promptly report any Quality Alert or issue to the Operations Quality Manager and the Quality Unit Manager and actively contribute to the resolution of significant quality issues.
• Ensure effective communication and collaboration with Production, Maintenance, Packaging, and other relevant functions to support product quality throughout its lifecycle.
• Management Indirect management of investigation teams.

Profile :

• University degree in Pharmacy, Chemistry or Biochemistry.
• Minimum 5 years in Quality Management in Pharmaceutical Industry, on a manufacturing site.
• Solid knowledge of cGMP, including Annex 1.
• Experience in lyophilized products and aseptic process.
• Indirect Management in project or investigation.
• Quality commitment, flexibility, initiative and problem-solving skills.
• Excellent team player with a strong ability to communicate.
• Fluency in French and English mandatory.

Ton interlocuteur/trice : Ton contact pour ce poste est Leila. Avec plus de 15 ans d’expérience dans le domaine du recrutement, il/elle saura t’accompagner, te conseiller et t’apporter la réponse à toutes tes questions concernant le poste.

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