QA Manager GMP/GDP
CK QLS are recruiting for a QA Manager GMP GDP to join a Biopharmaceutical Company based in Allschwil (Basel-Land) on a 1 year contract basis.
The company is specialized in the research and development of pharmaceutical, biological, and diagnosticproducts. It offers drugs for the treatment of insomnia, Fabry disease, cerebral vasospasm, resistant hypertension and lupus.
His/Her roles will have to:
- Provide GMP/GDP quality assurance expertise during development and commercialization ofIdorsia’s products
- For assigned projects, provide guidance on the resolution of complaints, testing issues, deviations, discrepancies and Out of Specifications (OOS), investigations and propose Corrective and Preventive Actions (CAPA) as needed
- Manage all required activities to support release of active ingredients, commercial products and/or investigational medicinal products including approval of master process documentation, batch record review and assessment of change controls
- Notify CMC team and management of potential quality, regulatory and lead time issues
- Assist in the conduct of GMP/GDP audits at 3rd party sites when needed
- Write, review, and/or approve internal SOP’s and GMP/GDP related Documentations
The candidate’s requirements:
- Master in Pharmacy, Chemistry or equivalent
- Previous experience in quality assurance of drug substance and/or drug Product and in pharmaceutical product development/ quality control/ analytical development/ chemical production
- Good knowledge of GMP/GDP
- Efficient and effective verbal and written communication skills in English and German (preferred)
Apply: Please could you send any correspondence in English. For more information contact Kajenthi Chelliah atKChelliah@ckqls.ch or 0041 (0) 800 106106. Please quote job reference 55201 in all correspondence.