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This position ensures compliance of computerized systems and associated processes with E2E APAC and expectations of health authorities. Within E2E APAC, the senior CSV/C specialist will work directly with operation teams and other quality team members. Within Merck, the senior CSV/C specialist will work with other necessary teams including but not limited to IT, Regulatory, and overseas global quality teams. The primary responsibilities of this position are ensuring data life cycle management, computerized system validation and participating in global projects.
- Establish and maintain QDS related to computerized systems in different GxP environments on regulatory basis.
- Determine and maintain data flow to realize data life cycle management.
- Responsible of data backup and archive.
- Supervise and manage the daily operation of computerized systems to guarantee data integrity.
- Participate in the development of system specific validation plans and strategy using a risk-based approach.
- Draft, review, and approve validation documents for computerized systems, and relevant infrastructure.
- Execute or direct the execution of validation testing, including change control, to impacted computerized systems.
- Lead and act as the Subject Matter Expert of CSV/C for routine quality operation, internal/external audits, health authority inspection and client communication.
- Provide regulatory support in field of CSV/C as per the request of customer or colleagues.
- Support the launch of different systems, e.g. LIMS.
- Accomplish other tasks assigned by line manager.
- Respect and follow EHS rules.
Who you are,
- Bachelor degree or above
- Major in computer science, engineering, or life science
- Minimum 5 years working experiences in field of CSV/C in pharmaceutical industry or third party.
- An expert in related regulatory requirements and industry standards, e.g. 21 CFR Part 11/210/211, Annex 11 of EU GMP, GAMP 5, ICH Q9/Q10, and etc.
- Proficiency in SAP, LIMS, MES, DCS, Empower, automation, and other pharmaceutical IT systems; data management systems.
- Knowledge of antibody development and production process
- Excellent training skills for providing both classroom training and on job training of CSV/C and data management.
- Fluent English speaking, reading and writing
- Good technical writing skills in English is a plus
Functional area: Quality
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