Beschreibung
SQA/CSV Lead - Long term Contract - Germany
As part of an ongoing global initiative for one of the world leading Pharmaceuticals, we seek an experienced Team Lead/Manager to take responsibility for the management of a CSV contract team. The duration will be long term with a competitive rate.
Leadership Responsibilities: Manage a team of CSV contractors; Give guidance on all activities related to computer and automation system validation. Review and approve documents prepared by the validation team. Execute all relevant validation protocols and test procedures, as defined by the Clients' IT SDLC methodology
Mandatory Requirements:
- 10+ Years exp. of Computer System Validation with at least 6 years: BIO/Pharmaceutical industry experience. 5+ Years: Demonstrated leadership in SDLC/CSV, IT Compliance and/or IT Quality Assurance. Experience with Managing/Training Offshore resources.
- Experience with equipment controlled by ERP, LIMS, EMS, PMS, and other Quality and Development Laboratory systems. Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11, and GAMP standards are required.
- Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred.