Ashutosh Kumar

Experience

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  PDPL

  Jan 2008 - Dec 2009

  Quality Control Executive

  Responsible for water Sampling, Air Sampling, Environment Monitoring.Analysis of Water Samples, Swab Samples and environmental Monitoring samples.Responsible for Preparation of Media.Responsible for Sterility Testing,Responsible for growth Promotion test.Responsible for Media fill, Autoclave Validation, Tunnel Validation, Area Qualification, Personal Qualification.Responsible for analysis of Biological endotoxin test.

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  Mylan

  Jan 2010 - Jun 2012

  Sr.Chemist

  Quality Control, Exposure of Regulatory audit like US-FDA, MHRA, MCC, ANVISA, TGA,Analysis of Stability sample, Finished Product sample and Raw Material Sample.Responsible for Stability Sample Management.Responsible for OOS, OOT and Investigation.Responsible for Document review and compilation as regulatory requirement's.Analysis of Stability samples, Finished product Samples.

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  Ranbaxy

  Jun 2012 - Jan 2015

  Quality Assurance

  Successfully complete Multiple Regulatory Audit like ANVISA, MHRA, TGA, MCC, HEALTH CANADA, TGA AND CUSTOMERS AUDIT. • Leading for In-Process Quality Assurance team size 15 members.• Responsible for review and approval of BMR, BPR, STP, Specification and Validation Protocol.• Responsible for Handling of Quality Management System like Deviation, Investigation, Change control, Out of specification, Out of trend, Market complaint.• Responsible for Vendor and Supplier Qualification for Contract Manufacturing of Tablets, capsule, Sterile manufacturing, Contract Laboratory, Packing Material, Raw materials and Active Pharmaceutical Excipients.• Responsible for Audit report review for audits done by team members.• Responsible for Review and preparation of audit compliance response, track CAPAs and ensure audit closure.• Responsible for Site Quality review meeting with respect of site performance.• Responsible for Regulatory audits and their compliance.• Handling Project of Data Integrity and Computer System Validation.• Responsible for Internal and External Quality Systems Audits and the CAPA implementation.• Handling of the investigations for deviations, OOS, OOT, Market Complaint and providing CAPA for the same.• Change control management.• Provide support to the various divisions for effective and efficient implementation of the Quality Management System.• Compilation of ANDA / Dossier and submission of annual updates for ANDA / Dossier.• Improvement projects by coordinating with Supply chain to increase the Lot Size of material with reduced testing. Cost saving & better utilization of Man Power. Show less

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  Jubilant generic Ltd

  Jan 2015 - Mar 2017

  Quality Operations Manager

  Regulatory compliance, Handling and successfully completed Regulatory audit Like US-FDA, MHRA, MCC, TGA AND Customers audit. • Responsible for Vendor and Supplier Qualification for Contract Manufacturing , Contract Laboratory, Packing Material, Raw materials and Active Pharmaceutical Excipients.• Leading In-Process Quality Assurance team size 40 members.• Responsible for review and approval of BMR, BPR, STP, Specification and Validation Protocol.• Responsible for Handling of Quality Management System like Deviation, Investigation, Change control, Out of specification, Out of trend, Market complaint.• Responsible Quality Improvement Projects like- Data Integrity Assessments,Computer System Validation of Electronic Instruments/Equipment’s, Cleaning Validation, Reduced Testing for In-process testing and Raw material sample analysis, Cleaning Validation, Process optimization, Process Validation.• Responsible for Overall audit program administration; organize annual audit schedule and execution.• Responsible for Conduct surveillance GMP and Quality System audits of contract manufacturing sites.• Responsible for investigate quality issues and significant events.• Responsible for Identify and report Quality and Compliance risks, gaps arising from audits.• Responsible for Audit report review for audits done by team members.• Responsible for Review audit compliance response, track CAPAs and ensure audit closure.• Responsible to Guide contract manufacturing sites for quality compliance and improvements.• Responsible for ensure compliance to organizational policies and procedures for functional areas.• Update department, CFTs on audit summary, trend, concerns from audit & Compliance• Pfizer Subject Matter Expert for Audit and Compliance and Data Integrity.• Responsible for Site Quality review meeting with respect of site performance.• Responsible for Regulatory audits and their compliance.• Handling Project of Data Integrity and Computer System Validation. Show less

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  Pfizer

  Apr 2017 - now

  Quality operation manager

  • Responsible to execute internal audit as a leader auditor.• Responsible Quality Improvement Projects like- Aseptic remidiation, Microbiology Laboratory modification,LSME, Data Integrity Assessments and Computer System Validation of Electronic Instruments/Equipment’s.• Responsible to assist the auditors during plant round and to provide relevant information.• Responsible for Preparation of Audit compliance response and monitoring their implementation and effectiveness.• Responsible for Quality technical agreement for existing/ new outsourced service provider.• Responsible for following QMS compliance – Change Control Management, Deviation Management, CAPA Management & CAPA effectiveness review.• Responsible for Microbiology Laboratory investigation like- Out of Specification and out of Trend results and preparation review and approval of Quality Risk Assesement report related to sterile manufacturing and Microbiology Laboratory.Responsible for preparation of Risk assesment report related to Material, Aseptic behaviour, pracatice.• Responsible for Audit & Compliance with Regulatory, Customer and Internal audits. • Responsible for initiation of FAR for Different regulatory agency and customers.• Responsible for External Audit for different Pfizer Sites like Manufacturing, Quality control, Quality Assurance and warehouse procedure.• Responsible for conduct Audit of Different contract Manufacturing Site & Contract Laboratory for cGMP Compliance.• Preparation of Audit Reports, monitoring there Compliance & Timely Closure of their Observations.• Responsible for tracking of audit compliance and their effectiveness checks.• Responsible for GAP assessment with respect to a regulatory observation like- USFDA, MHRA and other regulatory and Customer Audits.• Part of Project team who Perform Data Integrity assessment and Computer System Validation for Laboratory and Manufacturing system. Show less