QA Manager TRD

On behalf of our client in the Life Science industry, Harvey Nash is looking for a QA Manager TRD for a 12 month project in Switzerland.

You are responsible for:
- reviewing and approval of GMP relevant documents and decision making according to current SOP ("Global TRD QA and TRD Approval and Release Authorities") for the authority of QA Associate and special authority for DSM, and finally with authorities delegated to QA Team Leader of QA DSM.
- releasing authorities for clinical materials according to current SOP ("Global TRD QA and TRD Approval and Release Authorities"), with the authority of QA Associate and special authority for DSM and finally with authorities delegated to QA Team Leader of QA DSM
- managing Deviations, Investigations, CAPAs and contributes to or writes trending reports for level 2 Deviations/Technical Complaints/Change requests for products and processes of TRD GMP line units and recommends necessary actions to supervisor (Quality Matrix).
- contributing to or writing First Time Right performance reports for release of IMPs
- writing/reviewing SOPs
- supporting DSM in process improvements and in Qualitypromote and enforce compliance to guidelines. If managing associates, ensure same for them.

Requirements

- At least 2 years of relevant experience
- Education Minimum: Technician with continuing education (EU) or BS/MS (US) or equivalent
- Basic degree in scientific or relevant discipline (BS or equivalent)
- Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
- Ability to negotiate and communicate
- Sound scientific, technical and regulatory knowledge in a specific area
- Very good knowledge of cGMPs, working knowledge of safety andenvironmental regulations and guidelines
- Good knowledge of drug development
- Good organizational skills
- Good ability to analyze and evaluate GMP compliance
- Languages: Good knowledge in English (oral and written) required; fluent in site language (German)

Are you available immediately, have experience working within a Life Science company?

Please send your complete CV (Word documents preferred).

For further details feel free to call me.

I am looking forward to receiving your application.