QA Manager

  • Salary: Competitive
  • REF Number: 00052670
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 800 106 106
  • Date Published: 19.01.2022
  • Closed Date: 22.02.2022
  • Industry:
  • Location: Opfikon, Zurich/Zug Region
  • Functional Expertise: Science - QA/Validation

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.

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