Role And Responsibilities Perform and implement method development/qualification/validation/verification for new product and method introduction, compendial updates.
Keeps up to date on regulations/development of QC activities to ensure QC operations are in compliance to applicable regulatory and external agency regulations.
Lead and perform laboratory investigation and deviation.
Responsible to conduct effective training to ensure methods/knowledge are effectively transferred to routine testing team.
Write/reviews change controls, events' deviations, CAPA and GMP documents (e.g. SOP, protocols, reports, specification).
Provides technical expertise and consultation to routine testing team on technical matters.
Performs review of compendium updates timely and accurately.
Perform periodic review of test methods to ensure compliance to latest compendium requirements.
Ensure real time documentation, maintain data integrity and appropriate traceability.
Responsibl...