For our client OM Pharma specialized in biotechnology, localized in the Geneva, we are looking for a :
Quality System Projects Specialist
This position, act as the Quality System representative for technical projects, act as an QA expert cross functionally.
You participate in the preparation and follow-up of the Health Authority inspections.
- Act as Quality Management Representative for Technical Projects
- Write, review and/or approve project-related quality document such as quality policies, project quality plan, URS, VP, VMR, Risk analyses.
- Ensure the preparation and follow up of all change control related to the project.
- Ensure the Quality Compliance support related to Design within the field of Technical Projects
- Ensure Inspection Readiness
- Participate to the preparation of received audits (health authority inspections and audit partners)
- Act in front and/or back office during Health Authority inspections as needed
- Ensure inspection CAPA closure on time
- Act as internal GMP/GDP auditor (an asset)
- Act as a QA expert cross functionally
- Conduct quality risk analysis
- Write, review or approve SOP related to quality aspects
- Know and apply the company regulations regarding occupational Safety, Health protection and Environment
- University degree as Pharmacist, Biochemist, Chemist or similar
- Ideally 3 years' experience in a quality assurance function within the pharmaceutical industry
- Strong knowledge of the GMP guidelines' compliance (GXP.ICH,Ph,Eur,..)
- Technical Projects experience
- Fluent in French and English both in oral and written conversation
Please apply on-line. For more information, contact Ms Sophie Darthenay.