Product Quality Manager
Jocelyn Blackham is recruiting for a Product Quality Manager to join a global pharmaceutical company at their site based in Lucerne on a contract basis for 6 months.
The main purpose of the role will be to:
- Evaluate and/or release productsto other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations
- Play a key role in the primary batch release responsibility and ensures that effective and robust Quality systems
- Manage routine and complex deviations and complaints and assist in the coordination of significant investigations including Fact Findings
- Provide support for audits of EP/ExP by our Company and regulatory agencies
- Review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted
Further responsibilities will include:
- Stability Program management, including review of stability reports, and Annual Product Review assembly
- Track and monitor operational and quality performance of the external manufacturer/partner and can work with supplier to develop CAPA plans
- Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Degree in Science, Engineering or anyrelevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).
- Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred.
- Direct experience with managing external partners
- Experience with manufacturing operations and/or analytical expertise associated with biologics and/orvaccines. Aseptic manufacturing experience.
- Previous experience with regulatory communications such as Biologics License Applications (BLAs), New Drug Applications (NDAs).
This is an excellent opportunity to join a leading biopharmaceuticalcompany.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 51734 in all correspondence.
