Job Description
You will be responsible for manage C&Q activities of standalone instruments and equipment in WuXi biologics to ensure corresponding activities meet the relevant requirements of URS/SOP &GMP.
Key Responsibilities:
- Lead team to implement C&Q activities for standalone instruments and equipment as per master schedule.
- Ensure that standalone instruments and equipment are validated/qualified as per requirements and in compliance with GMP, industry standards and regulatory expectations.
- Complete the C&Q activities under general requirements of URS, GMP, and local site SOP.
- Coordinate all parties in C&Q, including internal and external team (3rd parties vendor, etc.), be able to keep active, willing to find out issues and focus on the key point and target as well, provide quick response and figure out related project issues.
- Support on CAPA/Deviation/change control process for evaluation of the qualification &valid...