Mangesh Chavan

Background

About Mangesh Chavan

I am Post graduate in Organic Chemistry with experience of 18 years in QC & QA departments with subject matter expertise in Data Integrity QC Testing Compliance Computer Systems QMS and Audit & Compliance .  Faced various audits as USFDA HPRA MHRA Health Canada ANVISA EMA and WHO etc. and assisted in preparing response to regulatory deficiency letter for HPRA/MHRA/USFDA Inspection.  Currently working in Serum Institute of India (SII) as Manager Quality Control and Accountable for the GLP compliance Lab Investigations Lab Safety internal audits Vendor Audit EHS and Risk management related to Quality department and Values & expectation of the Organization. Support to the production department to meet the manufacturing schedules by timely release of Raw materials / finished products/stability/validation/packaging material/ testing etc.  Also worked in reputed organizations (Mylan Sun Pharmaceutical Ranbaxy Emcure Pharmaceutical etc.). Working Experience in a Quality Control/Assurance roles in the Pharmaceutical Industry. Full understanding of cGMP regulations (EU & USA) and having a good knowledge of Quality System Processes (such as Change Control Deviation Document Control and CAPA etc.).  Proficiency in the Software’s such as Track wise LIMS SAP and Good knowledge of Laboratory instrumentation HPLC GC UPLC AAS FTIR UV-VIS spectrophotometer Dissolution NIR XRD TGA DSC Polarimeter and Malvern Master Sizer.  Having Good knowledge of Analytical Method validation Analytical Method transfer. IQ OQ PQ of all equipment’s and instruments. Management of Reference standard impurity standard & qualification of working standard.  Strong interpersonal skills and passion for work helps me undertake new challenges to collaborate with cross-functional teams vividly and to deliver on deadlines without compromising quality. Specialties: ☛ Technical writing - Audit response writing ☛ Review of OOS & OOT Investigations ☛ Quality Management system ☛ Instrument/ Equipment Qualifications & Computer System Validations ☛ 21 CFR part 11 & 211 compliance ☛ Data Integrity and QC Laboratory Compliance ☛ Risk assessment and mitigation. ☛ Root cause analysis & CAPA