Quality Auditor
4 settimane fa
Lu, Italia
CK Group
A tempo pieno
Job Title: Specialist Quality AssuranceWork 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:
- Reviewing batch record of clinical supplies which are packaged locally and at CMO, working cross-functionally with multiple stakeholders in multiple countries.
- GMP reviewing of the batch records and reviewing of the regulatory filings and the final release.
- 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:
- Review, and release of clinical finished goods, including review of the printed and applied label.
- Communicate batch related issues to management, EU Qualified Persons and the Swiss Responsible Person.
- Review and release of incoming label stock.
Your Background:
- Bachelor s or Master s Degree in life sciences required, ideally in biotechnology, biology or pharmaceutical studies.
- Master s Degree in clinical research, clinical data or clinical analysis is also advantageous.
- Minimum of 2-years experience in GMP environment within the pharmaceutical business or comparable.
- Experience in batch record review is advantageous.
- Preferably SAP and MS Word/Excel Experience.
- English and German language Proficiency at a business level is necessary.
Apply
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 106774 in all correspondence.
