- Perform analytical equipment lifecycle management as per current regulatory requirements / SOP.
- 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.
- Support and / or perform maintenance / calibration of laboratory equipment in compliance with established schedules.
- Liaise with vendors/service providers for PM / Calibration in a timely manner.
- Responsible for maintenance / calibration planning of equipment within QC Department.
- Ensure real time documentation, maintain data integrity and appropriate traceability.
- Responsible for the accurate, timely and compliant execution of assigned projects and related documentation.
- Assist / perform method validation and transfer as required.
- Conduct QC Department equipment operation and maintenance training to QC staff as required.
- Perform and / or support in maintaining the asset register for equipment in the QC Department.
- Initiate CAPEX for equipment purchase.
- Responsible for QC lab and equipment/instrument cleanliness.
- Any other activities as and when assigned by the Superior.
EDUCATION & EXPERIENCE
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
- Possess working knowledge of GMP in the pharmaceutical industry.
- A good team player with positive learning attitude.
- Working knowledge of validation, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
- Excellent interpersonal and analytical skills, good verbal and written communication skills.
