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Job Description：
This position is mainly responsible for the management of quality system in E2E APAC, including Biodevelopment Lab and GMP Facility, to ensure the system meet the quality requirements from customer, global functions and regulatory. The position will also focus on improving quality culture in BioVV APAC.
Internally, this position will work with all operation teams of Biodevelopment Lab ang GMP Facility and other quality team members in BioVV APAC. Externally, the Senior QA specialist will work with other necessary teams including but not limited to regulatory, quality teams of other functions and overseas global quality teams of Merck.
Main Responsibility：
Update and maintain quality system of Biodevelopment Lab and GMP Facility to keep up to date with operation, customer, cooperate and regulatory requirements
? Draft and establish quality relevant procedures;
? Define and manage document plan with operation teams;
? Follow up document plan implementation status;
? Review and approve SOPs from operation teams.
Overall documentation and record control to guarantee lifecycle management of quality documents in Biodevelopment Lab and GMP Facility
? Upload, distribute, maintain and archive quality documents, including records, logbooks, project documents, procedures, etc. on time.
Ensure training system of Biodevelopment Lab and GMP Facility is in place and followed to guarantee qualified persons are in positions
? Establish and maintain appropriate training modules according to functions and positions;
? Define site and personnel training plans, follow up the progress and review the results.
Lead self-inspection for continuous improvement
? Define annual self-inspection plan and lead each self-inspection accordingly.
? Schedule, prepare and conduct self-inspection, and publish self-inspection protocol and report.
? Immediately escalate critical observations to management.
? Review appropriateness of the CAPA Plan with the CAPA Assignee.
? Overall manage self-inspection in TrackWise System.
? Lead external audit from client, Agency and Global quality team.
? Lead KQI follow up and management review in both PD and GMP.
? As Site Lead User of electronic tools to provide trainings and manage accounts.
Provide regulatory support in field of quality system and quality operation as per the request of customer or colleagues
Accomplish other tasks assigned by line manager
Respect and follow EHS rules
Education
? Bachelor’s degree, above is a plus;
? Major in Pharmacy, Biotechnology, Engineering, Life science or related backgrounds

Experience
? 5 years+ of working experience in pharmaceutical, bio-pharmaceutical or life science industry
? Working experience of quality related fields (e.g. QA, validation, etc.)
? 3 years+ working experience in GLP or GMP environment
? Ability of regulatory precipitation
? Knowledge of antibody production process is a plus
? Successful project participation experience of establishing PD/GMP QMS, C&Q or NMPA/FDA/EMEA GMP certification is a plus
? Participation experience of customer project is a plus
Language Skill
? CET 4 or equivalent certification of English, above is a plus
? Sufficient English reading and writing ability
? Fluent English speaking is a plus