Executive Quality Control
Pfizer Healthcare Ltd.
Total des années d'expérience :14 years, 5 Mois
Implement & manage the Pfizer Quality Management System at the site compliant with cGMP guidelines covering testing, documentation, storage of products.
To perform, plan and review the quality routine analysis of raw materials, in process, finish products, stability samples, validation samples through wet methods and instrumental methods using instruments like HPLC, UPLC, UV, FTIR, GC, Dissolution apparatus, DT apparatus, Density meter, Osmometer etc.
Develop & implement quality systems and validate all systems, methods, processes & equipment against applicable GMP protocols.
To actively participate in the investigation of major deficiencies reported in processes & products (OOS, OOT, deviation management in gQTS) to identify root causes and recommend effective corrective & preventive action (CAPA) action plans to the site senior management.
To actively participate internal audits related cGMP compliance, coordinate external audits by regulatory bodies and ensure closing of all observations through effective CAPA.
Develop & deliver training programs for staff across functions & levels to build & sustain a culture committed to cGMP compliance
Coordinate all activities related to product release including all testing and documentation protocols to meet regulatory requirements
Design & deliver instructor led training programs covering all aspects of the quality assurance function.
As an active member of the Exhibit stability team, contributed to resolution of quality related compliance issues across the site.
To analyse and review the routine laboratory samples (Tablets, capsules, Softgelatin) by wet methods and instrumental methods (HPLC, UV, FTIR, DR).
To participate actively in routine laboratory investigations(OOS, OOT, deviations).
Managed personnel executing activities related to quality testing and product/process quality & reliability assurance.
To plan, analyse, review the routine laboratory samples (Tablets, capsules, Softgelatin, Injections) by wet methods and instrumental methods (HPLC, GC, UV, FTIR, DT).
To look after the successful technology transfer of softgelatin capsule to other sites.
To perform the calibration, qualification of all the laboratory instruments like HPLC, UV, FTIR, pH meter, Weighing Balance
To perform the joint analysis at other premises, technology transfer to other premises.
Evaluated all equipment on parameters of performance, quality, assessed scope for improvements and developed effective strategies for enhancing overall performance
Maintained production related inventory records of the module, ensured cGMP compliance and participated in internal & external audits
Generated reports from the SAP system for monitoring lead time, cycle time and overall equipment efficiency (OEE) and identifying scope for improvements
➢ M.Sc. (Pharmaceuticals Chemistry) from H.N.B Gharwal University Srinagar in 2009.
➢ B.Sc (medical) from H.P. University Shimla in 2007.