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, tels que la banque, sociétés financières, multinationales, ONG, PME et institutions locales.
Nous souhaitons recruter un/e Quality Assurance Specialist – Manufacturing – Permanent position – 100%
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. Ce job ne correspond pas tout à fait à ce que tu cherches mais nos valeurs te parlent ? N’hésite pas à nous adresser ta candidature spontanée ! Nous ne répondrons qu’aux candidatures dont le profil correspond au descriptif demandé. jpid69da1f1jm jpit0832jm jpiy26jm
