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 &validation status.
- Ensure current validation expectations, participate in continuous improvement work, and other superior assigned work.
- Support C&Q related audit/visit by clients and regulatory authorities.
Requirement:
- Bachelor’s degree or higher in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, or related scientific/engineering discipline.
- Minimum 8+ years' experience in CQV area and 3+ years management background and familiar with the C&Q of facility, utility, equipment and instruments.
- Familiar with related regulatory requirements and industry standards, such as NMPA/EMA/PICS GAMP5,FDA 21CFR Part 11/210/211,ISPE,ICH Q9/Q10,etc.
- Hands-on experience in writing, reviewing, and executing DQ, IQ, OQ, PQ protocols and reports.
- Strong experience in a commissioning, qualification and validation role for biologics or pharmaceutical industry in a FDA/EU/Singapore related environment.
- Strong project management and communication skillset.
- Good at management/coordination of 3rd parties.
- Familiarity with software validation and computerized system compliance.
- Overseas Travelling may require for project implementation.