Senior CSV QA Manager - SCSV-QAM-IDO-3786

Allschwil, Switzerland

Posted:40 days ago
Sector:Pharmaceutical
Location:Allschwil, Switzerland
Job Ref:BH-33162
Job Type:Contract
Salary:CHF55 - CHF75 per hour
Expiry date:12/6/2022
Contact:Jason Batzofin
Contact Email: jason.batzofin@xplorelifescience.com

Xplore Life Science is hiring an experienced

CSV QA Manager


The role is for a global leading biopharmaceutical company headquartered in Allschwill, Switzerland.

**You must have valid right to work in Switzerland 


This is a freelance contract role with a minimum 12-month duration and immediate start.


Key Responsibilities:

  • Ensure compliance with the computerized system.
  • Ensure that GxP-regulated systems are managed in accordance with regulatory requirements.
  • Perform CSV activities and support efficient integration of Data Integrity.
  • Provide support, guidance and advice with regard to computerized system validation within the GxP area, 21 CFR Part 11 and EU GMP Annex 11.
  • Ensure compliance with the computerized system lifecycle.
  • Perform and coordinate internal and external audits.


Requirements:

  • Master’s degree within the pharmaceutical industry.
  • At least 7 years experience in Computerized Systems Validation (CSV).
  • Understanding of regulatory requirements such as GxP & 21 CFR Part 11 and GAMP5 guidelines, EU GMP Annex 11.
  • Fluent in English. German and/or French are an advantage.


Apply now