Senior QA Specialist – GMP Manufacturing Excellence

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

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.