QA Dept. Head- STA JS
This position is based in Shanghai-JS, China, reporting to QA/QC Executive Director at WuXi AppTec.
Job responsibilities include but not limited to:
- Review and approve all quality related procedure documents and quality manual according to GMP regulations.
- Establish, optimize and maintain the company quality system, ensure the regulator compliance and operability.
- Define effective CAPA, ensure a continuous quality system improvement by deviation investigation, quality incident handling, product quality review, self-inspection and external GMP inspection..
- Ensure good communication with clients and authority, maintain company quality imagination.
- Follow client quality agreement, meet client quality expectation..
- Receive client auditing and authority inspection, respond the audit report and follow up the actions.
- Review and approve VMP and validation documents, ensure that the company validation activities meet GMP requirement..
- Organize quality training, increase the quality awareness of employees.
- Fulfill QP responsibility as SFDA requirement.
- Major in pharmacy/chemistry, bachelor degree or above.
- Very known the production/inspection & QA management in Pharmaceutical industry, familiar with GMP requirements.
- Strong communication and presentation skill.
- Fluent in English both oral and written.