1. Perform analytical equipment lifecycle management as per current regulatory requirements / SOP.
2. Involve in equipment qualification, writing URS, reporting and implementing SOP’s for system operation and maintenance, monitoring performance of the equipment and decommissioning of equipment.
3. Support and / or perform maintenance / calibration of laboratory equipment in compliance with established schedules.
4. Liaise with vendors/service providers for PM / Calibration in a timely manner.
5. Responsible for maintenance / calibration planning of equipment within QC Department.
6. Ensure real time documentation, maintain data integrity and appropriate traceability.
7. Responsible for the accurate, timely and compliant execution of assigned projects and related documentation.
8. Assist / perform method validation and transfer as required.
9. Conduct QC Department equipment operation and maintenance training to QC staff as required.
10. Perform and / or support in maintaining the asset register for equipment in the QC Department.
11. Initiate CAPEX for equipment purchase.
12. Responsible for QC lab and equipment/instrument cleanliness.
EDUCATION: Degree / Diploma in science related discipline (e.g. Chemistry, Chemical Engineering, Biotechnology).
EXPERIENCE: Minimum 4 years of quality control experience in pharmaceutical manufacturing industry.
KNOWLEDGE & SKILLS:
1. Possess working knowledge of GMP in the pharmaceutical industry.
2. A good team player with positive learning attitude.
3.Working knowledge of validation, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
4. Excellent interpersonal and analytical skills, good verbal and written communication skills.
