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Within E2E APAC, the senior validation specialist will work directly with operation teams and other quality team members. Within Merck, the senior validation specialist will work with other necessary teams including but not limited to Technology, Field Service, Regulatory, and overseas global quality teams. The primary responsibility of this position is ensuring the delivery of all validation relevant works.
2. Main Responsibility
- Establish, maintain and update QDS relevant to validation, calibration and maintenance.
- Participate and manage GMP validation project in a risk-based manner. Establish on-site QPP for validation project.
- Prepare and update site VMP and trace validation execution status in terms of VMP.
- Manage SAT and FAT activities.
- Review validation related documents (SIA, URS, DQ/IQ/OQ/PQ protocols, records and reports) including but not limited to equipment, utility, analytical method, cleaning, production process and transportation.
- Manage outsourced validation team and support validation implementation. Coordinate involved departments in validation activities
- Overall management of calibration and maintenance. Establish schedule and inform operation team before due date. Review and archive relevant documents.
- Ensure compliance and data integrity during all activities of validation, calibration and maintenance.
- Maintain validation, calibration and maintenance databases to ensure timely update.
- Lead and act as the Subject Matter Expert of validation for routine quality operation, internal/external audits, health authority inspection and client communication.
- Provide regulatory support in field of validation as per the request of customer or colleagues.
- Accomplish other tasks assigned by line manager.
- Respect and follow EHS rules.
Who you are:
- Bachelor degree or above
- Major in Pharmacy, Biotechnology, Engineering, Life science or related backgrounds
- Minimum 5 years working experiences in field of validation in pharmaceutical industry or third party.
- Solid knowledge of cGMP, FDA, EMEA, ASME, and national standards relevant to validation.
- Rich experience in green field projects.
- Familiar with pharmaceutical facilities, utilities and equipment.
- Knowledge of antibody production process
- MNC or third party working experience
- Knowledge of handling validation instruments.
- Fluent English speaking, reading and writing
- Good technical writing skills in English is a plus
Functional area: Quality
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