默克投资(中国)有限公司新闻资讯

This position will be responsible for the validation of equipment at Biodevelopment lab, overall calibration management of equipment at Biodevelopment Lab and GMP facility. The primary responsibility of this position is ensuring the status of all equipment and utilities compliant to operation and regulatory requirements.

Within E2E APAC, this position will work with all operation teams of Biodevelopment Lab and other quality team members of E2E. Externally, the validation specialist will work with other necessary teams including but not limited to Technology, Field Service, Regulatory, and overseas global quality teams of Merck.

Overall validation management to ensure equipment are in appropriate validated status in Biodevelopment Lab

• Assess validation needs for equipment;
• Prepare and update site VMP and trace and summarize validation execution status, prepare VMR;
• Review and approve validation related documents;
• Ensure compliance and data integrity during all activities of validation.
• Participate in PQ of GMP facility, review PQ protocols and reports.

Overall calibration management to ensure instruments are calibrated properly in Biodevelopment lab and GMP facility

• Assess calibration needs for instruments;
• Maintain calibration table and schedule calibration;
• Review and approve calibration related documents;
• Ensure compliance and data integrity during all activities of calibration.

Manage computer systems to realize data management for Biodevelopment Lab

• Maintain computer configurations and manage accounts;
• Perform routine audit trail review;
• Ensure timely data backup.

Preventative maintenance management for process equipment and analytical device

• Assess maintenance needs;
• Maintain maintenance table and schedule maintenance;
• Review and approve maintenance related documents;
• Ensure compliance and data integrity during all activities of maintenance.

Assure equipment are properly labelled according to validation, calibration and maintenance status

Perform routine environment monitoring in Biodevelopment lab.

Provide regulatory support in field of validation, calibration and data integrity as per the request of customer or colleagues

Lead and act as the Subject Matter Expert of validation, calibration, preventative maintenance and data management for routine quality operation, audits and client communication

Accomplish other tasks assigned by line manager

Respect and follow EHS rules               

Autonomy:

·         Autonomy in the daily management of equipment in aspects of validation, calibration and preventative maintenance.

·         Autonomy in data management.

Can be replaced:

·         Completely by the QA Debuty

·         Completely by another Validation Specialist.

·         Partially by another peer QA specialist.

Can replace:

·         Part of the QA Debuty.

·         Completely another Validation Specialist.

·         Part of another peer QA specialist.              

Education

• Bachelor’s degree or above
• Major in Pharmacy, Biotechnology, Engineering, Life science or related backgrounds
• span>

Experience

• 2-5 years+ of working experience in pharmaceutical, bio-pharmaceutical or life science industry.
• 3 years+ working experience in GLP or GMP environment
• Familiar with pharmaceutical facilities, utilities and equipment
• Working experience of quality related fields (e.g. QA, validation, etc.) is a plus
• Successful project participation experience of establishing PD/GMP QMS, C&Q or NMPA/FDA/EMEA GMP certification is a plus
• Knowledge of antibody production process is a plus
• Knowledge of handling validation instruments

Language Skill

• CET 4 as minimum or equivalent certification of English
• Capable of English reading and writing
• Fluent English speaking is a plus