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Key Roles and Responsibilities:
Lead equipment and lab instrument (computerized and non-computerized) qualification
Perform routine calibration and preventive maintenance activities and coordinate with external service providers when required
Perform routine data backup and archival
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 process 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 validation.
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.
Full time on-site work requirements
Job ID: 144119881