QA Reviewer

Job Description

Position: Executive R&D Quality, CMC QA _ Commercial QA Support Grade: G12A Job Location: Vadodara Job Responsibilities: (PE Center) 1. Review of protocol/reports (Pharmaceutical Equivalence Report and Comparative Dissolution Profile Report) and other analytical documents related to Pharmaceutical Equivalence (PE) Center. 2. Review of QMS documents (Out of Specification/ Lab event/Planned deviation /Un planned deviation/Investigations/ CAPA/Change control). 3. To assist in developing procedures / quality system and assure compliance of the same by identifying gap through document review and Audits. 4. Review of SOPs for the compliance of the cGxP requirements and monitoring its implementation. 5. To provide support for computerised systems implementation into PE center and act as Process Quality Lead (PQL) for Validation of computerized system. 6. Review of documents, approve discrepancy note and handle quality activities of Medicinal Product Store. 7. To assess the compliance level of PE center through Self Inspection / Internal Audit program. To support all time readiness for successful regulatory inspection at PE center. Desired Candidate Profile: M. Pharm / M. Sc. with 5-7years of experience in manufacturing QC / R&D Quality involved in GMP operation. Worked in GMP area and well aware about GMP requirements for as per FDA, ANVISA, HC. Good oral and written communication skill Shall be well versed and have experience on quality management system, review of AMV, AMT, PE Certificate, CDP Report, qualification, and analytical raw data review. Shall be well versed with OOS, OOT, Investigation, Deviation, CAPA management & ANVISA PE center requirement