CQV Specialist

For our partner located in the canton of Bern, GI Life Sciences is looking for a: CQV Specialist

Start date : ASAP

Your responsibilities:

· Collaborate closely with the Engineering and CQV teams.

· Ensure qualification activities are compliant with GMP standards.

· Participate in issue assessment and management in collaboration with other departments (Engineering and CQV).

· Contribute to the continuous improvement of quality standards and issue management.

· Write validation protocols and reports.

· Review and approve specific C&Q/URS, RTM/QRA/IOC documentation according to standards.

· Review and assess project gaps when necessary.

Profile:

· Master's degree in biology, chemistry, or equivalent.

· Minimum of 5 years' experience in qualification and validation in the pharmaceutical or biotechnology industry.

· Experience with GMP, qualification, process validation, and quality risk management.

· Commissioning experience on large-scale projects.

· Fluent in English and French; any additional language is a strong asset.

Your GI Life Sciences contacts:

Kévin Chauvin

0041.22.737.12.02

0041.22.737.12.01