QA Manager
Silke-Kathrin Kroh is recruiting for a QA Manager to join a global pharmaceutical company at their site based in Zurich on a contract basis until the end of September 2022.
The main purpose of the role will be to:
- Manage interface and interaction with CMO (weekly QA meetings, individual follow up meetings) in regards of batch disposition and investigation progress
- Review batch documentation provided by CMO for completeness, correctness and compliance to Marketing Authorization application
- Perform internal batch disposition acc. company's SOP and acc. to change control status
- Mirror CMO deviations in company's investigation system, lead investigation with internal and external partners and ensure closure on time
Further responsibilities will include:
- Weekly status updates to be provided on work package completion
- Participation in weekly internal QA meeting to update on progress and align on next steps and issue/comment resolution
- Participation in jointCMO QA meeting
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Bachelor's Degree or higher in Chemistry, Biology, or Life sciences, or equivalent scientific discipline
- Previous experience in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industries.
- Good Manufacturing Practice quality assurance experience.
- Experience with equipment, instrument, analytical method and process validation is an asset
- Experience in routine office software packages and specialized software applications as appropriate.
This is an excellent opportunity to join a leading pharmaceutical company.
For more information or toapply for this position, please contact Silke-Kathrin on 0041 (0) 800 106 106 or email skroh@ckqls.ch. Please could you send any correspondence in English. Please quote reference 52670 in all correspondence.