Product Annual Review: Initiates and facilitates Product Annual Review activities, Tracks recommendations and ensures action plan completion & Compiles reports for approval.
Deviation/OOS/Customer Complaints: Participates in investigations, reviews and approves investigation reports, Tracks Corrective Actions/Preventive Actions, etc.
Product Release: Performs batch disposition and updates in the system, Reviews and closes batch-sheet and related documentation, etc.
Change Control: Reviews and approves change control request, qualification activities from quality perspective. Acts as Quality representative in change control meetings.
Develop and oversee plans for capital projects or initiatives such as new product introduction.
Maintains appropriate quality oversight of SOPs for manufacturing and operational activities.
Approval of IQ, OQ, and PQ protocols for complex systems. Identifies validation issues and supports development of remedial actions.
Graduate in Science/Life science, Pharmaceutical Science or Chemical Engineering
3-5 years of relevant experience in quality assurance in pharmaceutical / bio pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA and EMA.
Quality assurance/operations experience in a sterile manufacturing plant is strongly preferred.
Proactively anticipating quality risk across various phases of product lifecycle to develop and integrate improved mitigation plan and techniques based upon product types and associated technologies.
Other expectation includes a comprehensive knowledge of Quality system, able to interprets and apply the quality system to quality standard, as well as demonstrate the ability to independently solve problems and make prompt decisions as guided by policies and procedures.