Responsible for the overall operation of the QA/QC, Production, Warehouse, EHS, Personnel & Quality of Products. Organize daily QMS huddle meeting with Head of Department of QA,QC, Production , Engineering, Ware house, EHS & Personnel & resolve the issues trough incident, Change control OOS.
Ensured that quality system are in place & efficiently managed (CAPA, Deviation, Change control complaints, SOPs, Audit programme, Quality investigation).
Performed risk assessment of Aseptic manufacturing & filling of injectable, Media fill simulation, Cleaning & disinfection of Clean area Water system, Personnel movement in clean area and risk analysis.
Handled OOS/OOT of Environmental monitoring, Sterility test, BET test, Water system, HVAC, etc. Performed risk analysis and provided CAPA. Performed Risk analysis concern to Microbiology, Documents Management & Control of Microbiology & Chemical section through data integrity, Microbial sampling technique.
Conducted daily QMS and huddle meeting for resolved the issues through, Incident, change control, work order system and maintained cGMP/cGLP.
Close coordination with multifunctional team such as R&D, RA, Production, Quality Control and Ware House in the existing facility for incidents, huddles and review of, Quality Manual, SMF, MFR, VMP, BMR, BPR, Specifications, STPs, SOPs, Annual Product review, etc.
Conducted inspections at various stages (planned as well as random) to ensure safety & quality compliance of the specifications, without any slippages.
Provide feedback to top management based on quality audits & rendering suggestions for improvement.
Taken initiatives through various training programs in coordination with training teams to optimise and take corrective actions on the basis of quality checks and Handling the market /Customer complaints.
Reviewed and approved qualification and validation of new set up of Clean area, Water system, HVAC, steriliser, tunnel, biosafety cabinet, mfg/filling vessels, Hold time study, Disinfectant validation, Cleaning validation, SIP/CIP, Personnel Qualification, Microbiologist qualification, Cold chain validation and also Vendor qualification .
Leading dedicated team of Assist Managers, Executives, Chemist, Microbiologist working in Quality Control Dept. Steering efforts towards ensuring due diligence of all laboratory systems and equipments in compliance with c GLP, WHO GMP.
Resolve the quality issues related to Water system, Environmental monitoring, personnel monitoring, media fill, and hold time study, effective of cleaning of disinfectant used in clean area by using tools of risk assessment as per ICH Q9.
Troubleshooting laboratory test problems and communication of technical information/data updates to Quality Assurance, Manufacturing, and Regulatory Affairs as required.