QC Compliance Baxter Global Research & Development (BGRC) SYNGENE International Ltd., Expertise in preparation and review of Instrument/ Equipment’s Qualification (IQ, OQ & PQ) and Calibration documents, to maintain properly for technical and GDP compliance. Computer System Validation (CSV) as per GAMP5 (Good Automated Manufacturing Practice) as well as regulatory requirements 21 CFR part 11, part 210, 211, and 820, & EU Annex 11 assessment. CSV life Cycle documents like SCA, Vendor Assessment, VP, Risk Assessment, DS, CS, IQ, OQ, & PQ Protocol, Traceability Matrix, VSR, and SRC. Review of SOPs, IOPs, and EOPs as per the regulatory and quality requirements. Self-inspection, Internal quality audit, and providing responding to client and regulatory bodies. Qualification of new instruments. Training management. Reference standards management.

Abbott Nutrition Research and Development in SYNGENE International Ltd.Responsible for maintaining lab compliance and implementation in the Laboratory as per regulatory requirements (ISO – 17025). Preparing and sending the reports to clients. Preparation and review of SOPs, IOPs, EOPs, and analytical documents. Stability Studies Management – Monitoring the stability chambers Planning and Scheduling the Stability samples testing as per the stability protocols, Data reviewing, Trending, and Report releasing to the customers. Responsible for analytical instruments calibration and review of reports. Periodic calibration schedule monitoring, calibration, and review of reports. Responsible for Customer complaints management to all the lab-related activities, test reports, laboratory investigation, and stability data compilation. Daily routine lab rounds and monitor the day-to-day requirements to meet regulatory compliances. Conducting Customer feedback and evaluation. Participating in international proficiency testing. Handling and investigating LIRs.

ExecutiveDownstream process of Monoclonal antibodies. Liquid-Liquid chromatography, Affinity, Ion Exchange, SEC, HIC chromatography, and TFF filtration.Effective operations of the plant. Production planning & scheduling, achieving daily production targets. Scheduling material procurement plans, ensuring that inventory of raw materials.Creating Standard Operating Procedures, BMR, EOP, IQ, OQ, PQ.