In view of our continued global growth, we are looking for a Quality System Projects Specialist at OM Pharma in Meyrin/Geneva.
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.
Your main tasks are the following:
- 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
For this challenging position, we are looking for a rigorous and solution-oriented person bringing the following profile:
- 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
You are a pragmatic person who likes to identify and solves problems from the roots. Responsible and methodical, you enjoy taking initiatives and demonstrate a rigorous approach with high attention to details. You have excellent organizational skills and prioritize according to needs. You are an open communicator with good interpersonal skills, who is able to build good working relationships with colleagues.
If this sounds like you please do apply to this new position with us at OM Pharma in Meyrin/Geneva.