Key Roles and Responsibilities:
- Lead routine calibration and preventive maintenance activities and coordinate with external service providers when required
- Manage chemicals, reagents, consumables required for routine calibration and preventive maintenance
- Lead routine data backup & archival, account management and time sync
- Lead deviations and CAPAs writing
- Any other tasks assigned by manager
Job Requirements:
Bachelor degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related discipline or equivalent
At least 2 years of validation experience in GMP environment
Clear end-to-end understanding of validation, PM & CAL processes and DI requirements in GMP environment
Good command of both written and spoken English.
Other Special Requirements:
- A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.
- Proven track record in instrument/equipment calibration and maintenance in GMP setting.
- Strong understanding of DI requirements in GMP environment.
- Fast learner, independent, resourceful, and able to work in a fast-paced environment.
- Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoeias.
- Fulltime on-site work requirements
