Quality Assurance Specialist - Manufacturing - Permanent position - 100%

Job-Room; Genf; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Job-Room is seeking a Quality Assurance Specialist – Manufacturing for a permanent, 100% position in Genf. You will ensure production quality is compliant with policies and directives, lead deviations and investigations, and drive CAPA actions across manufacturing, maintenance, packaging and lab activities.

You will review GMP documents, participate in risk analyses, support audits, and train staff in classified areas while collaborating with cross-functional teams to safeguard product quality.

Qualifikationen

• 5+ years in Quality Management in Pharmaceutical Industry.
• Solid knowledge of cGMP, including Annex 1.
• Experience in lyophilized products and aseptic process.
• Fluency in French and English mandatory.

Aufgaben

• Ensure activities related to the production quality are conform with company policies and Quality directives.
• Lead and manage deviations, coordinating investigations with relevant functions.
• Define, implement and follow CAPA with timely execution and effectiveness.
• Manage complaints investigations and resolution.
• Review/approve GMP documents for production area (SOPs, specs, reports).
• Participate in risk analyses with cross-functional teams.
• Audit self-inspections and external audits; support authorities.
• Train staff for classified areas and review batch records.
• Release incoming consumables and review packaging batch records.
• Report Quality Alerts promptly to Operations Quality Manager.

Kenntnisse

Quality管理

cGMP knowledge

Risk analysis

Auditing

Ausbildung

University degree in Pharmacy, Chemistry or Biochemistry

Jobbeschreibung

Quality Assurance Specialist – Manufacturing – Permanent position – 100%

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