Job Description

WHAT YOU WILL DO: * Product Release: Reviews manufacturing & cleaning batch records and related electronic data, performs batch disposition of Intermediates and Drug Substance. * Annual Product WHAT YOU WILL DO: Product Release: Reviews manufacturing & cleaning batch records and related electronic data, performs batch disposition of Intermediates and Drug Substance. Annual Product Review: Initiates and facilitates Annual Product Review activities, tracks recommendations, and ensures action plan completion & compiles reports for approval. Deviations/Complaints: Participates in investigations, reviews and approves investigation reports, tracks & approves Corrective Actions/Preventive Actions, generates deviation summary reports. Performs quality review and approval of process, equipment & analytical change controls. Ensures robust material control strategy is in place for all change controls Provides QA oversight on qualification/validation, technology transfers, and commercial operations at the API facility. Supports Quality review and approval of SOPs, Master Batch Records, Quality Critical Alarm Forms and Quality Risk Assessments conducted at API site. Reviews supplier qualification documents, change controls and conduct Supplier Performance review. Establish & manage Quality Agreement for assigned suppliers Conducts or participates shop floor visits (GEMBA) adhering to site safety procedures whenever required, manages retention samples for API site along with teammates. Supports HA, internal and external customer audit requests pertaining to QA function. WHAT YOU MUST HAVE Qualification & Requirements Bachelor's Degree in Science/ Life Science, Pharmaceutical Science or Engineering or proven relevant experience. 2 - 5 years of experience in Pharmaceutical Industry. Quality Assurance experience in API/Drug Product manufacturing environment supplying to highly regulated markets such as FDA and EMA is preferred Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements. Good knowledge of Singapore, US and European regulatory requirement Ability to work as part of a team and on own initiative in a constructive manner Flexible and self-motivated