Quality Auditor - II - P2
Job Title : Specialist Quality Assurance
Work Location : Lucern
Country : Switzerland
Duration : 12 months
Rate : CHF 42.55 phr - CHF 51.71 phr (8 hours per day) depending on experience
Your main duties as a Specialist Quality Assurance will include:
1. Reviewing batch record of clinical supplies which are packaged locally and at CMO, working cross-functionally with multiple stakeholders in multiple countries.
2. GMP reviewing of the batch records and reviewing of the regulatory filings and the final release.
3. Collaborating closely with our internal functional areas (i.e. GMP Manufacturing & Packaging & Logistics, Comparator Planning, Clinical Quality, Clinical Research Associates, Central Complaint Handling Unit, Batch releasing Quality) and external partners (i.e. Contract Manufacturing Organizations,).
Additional duties will include:
4. Review, and release of clinical finished goods, including review of the printed and applied label.
5. Communicate batch related issues to management, EU Qualified Persons and the Swiss Responsible Person.
6. Review and release of incoming label stock.
Your Background:
7. Bachelor’s or Master’s Degree in life sciences required, ideally in biotechnology, biology or pharmaceutical studies.
8. Master’s Degree in clinical research, clinical data or clinical analysis is also advantageous.
9. Minimum of 2-years’ experience in GMP environment within the pharmaceutical business or comparable.
10. Experience in batch record review is advantageous.
11. Preferably SAP and MS Word/Excel Experience.
12. English and German language – Proficiency at a business level is necessary.