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Job Description Position: Senior Officer / Executive - R&D Quality, CMC QA _ Commercial QA Support Grade: G12A, G12B No of Positions: 2 No. (one for PE Center Compliance and one for 100% raw data review) Job Location: Vadodara Job Responsibilities: (PE Center) Review of protocol/reports (Pharmaceutical Equivalence Report and Comparative Dissolution Profile Report) and other analytical documents related to Pharmaceutical Equivalence (PE) Center. Review of QMS documents (Out of Specification/ Lab event/Planned deviation /Un planned deviation/Investigations/ CAPA/Change control). To assist in developing procedures / quality system and assure compliance of the same by identifying gap through document review and Audits. Review of SOPs for the compliance of the cGxP requirements and monitoring its implementation. To provide support for computerised systems implementation into PE center and act as Process Quality Lead (PQL) for Validation of computerized system. Review of documents, approve discrepancy note and handle quality activities of Medicinal Product Store. 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. Job Responsibilities: (Commercial QA and QMS Support) To ensure the compliance requirements of Quality Agreements / Contract Testing Agreements at R&D (Review, Management, Maintenance and other quality related activities). To assist in developing procedures / quality system and assure compliance of the same by identifying gap through document review and Audits. To review QMS documents for cGxP compliance and centralised QA oversight for GMP Laboratories (GxP Sections). To review documents, approve discrepancy note and handle quality activities of Medicinal Product Store to ensure the compliance of cGMP requirements. Review / Prepare SOPs for the compliance of the cGMP requirements and monitoring its implementation. Review, Monitoring and managing In-vitro BABE study to ensure compliance as per regulatory requirements and established procedure. Responsible to ensure GxP Computerized Systems at GxP laboratories, are in compliance with the current regulatory standards. Ensure implementation of relevant quality policies, standards and procedures for computerized systems To provide support for computerised systems to be implemented into R&D and act as Process Quality Lead (PQL) for Validation of computerized system. Review and approve of inventory of computerized systems and infrastructure, at site and ensure its compliance status. Author / review the site Computerized System Validation Master Plan (CSVMP) as per the quality procedure. Approve documents related to computerized systems which are generated as a part of CSQMS GSOPs. Review and approve System release and retirement documents as per the quality procedures. Review and Approve validation deliverables and lifecycle documentation for computerized systems as a Process Quality Lead. Ensure the periodic activities as per the quality procedures are performed in a timely manner. Mentoring and supporting site cross functions to resolve issues related to computerized systems. Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives. Lead to present/discuss and define way forward for fast-track remediation of open action items related to computerized systems in site QRB meetings. To review and approve external sample analysis reports. To assess the compliance level of the all the GxP departments through Self Inspection / Internal Audit program. To support all time readiness for successful regulatory inspection at R&D. Perform other duties as assigned by reporting manager time to time. Key Word For Search in Job Site : R&D Quality, QC, GMP, PE Center, Quality and Compliance 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
