Sanjay S Patil

+ (91-955******* / (91-733******* Email: adjk3l@r.postjobfree.com/adjk3l@r.postjobfree.com

LinkedIn URL: https://www.linkedin.com/in/sanjay-s-patil-22370432/

Quality Assurance Audits SME –Microbiologist Injectable and QMS

EXECUTIVE SUMMARY

Strategic QA/QC professional & leader, having more than 24 years of rich & insightful experience in the Pharmaceutical industry, with a niche across Quality Assurance, Quality Control and Technical services (Sterile and non sterile dosage forms, Biogicals and API). Expertise in handling microbiology lab, Audit handling & response, Qualification/Validation of Facility & system, Projects handling & risk assessment/Management, CAPA implementation and Self-Inspection. Sound knowledge of software systems like Metric stream-Audit Management module, Change control, Exception, PNC, MNC, CAPA module, TRIMS, DMS, SAP, ERP. Worked in Solid Orals (tablet/Capsule), Injectable (DPI and Lyophylizations), and departments. Certified Auditor for Auditing GMP facilities.

Areas of Excellence include:

Strategy & Leadership:

nPlay a pivotal role in defining QA/QC roadmap and represent QA at senior management, project, Board, and review meetings

nProvide direction and guidance to the Quality team, while managing, motivating, coaching and mentoring direct reports

nEnsure good relations and communications with all members of the team and responding in a timely fashion to internal and external customers

nShoulder Budgetary and managerial responsibility for Quality Assurance and Quality Control

Quality Assurance:

nDevelop, implement, manage, audit and maintain GMP quality systems; develop, manage & maintain a GMP compliant document control system

nCoordinate and perform all vendor qualification and compliance audits

nEnsure that cGMP requirements and quality standards are recognized, understood and maintained across the Company

nWork across all disciplines (e.g. manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies

nKeep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes

nMaintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost; Also ensure they are fit for purpose- operationally and commercially

nEnsuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies

Quality Control:

nManaging all validation activities, including validation strategy and approval of protocols and reports

nHandle the Documentation activity for preparation of Standard Operating Procedure, preparation of specification, Method of analysis, Protocol preparation, control of protocol and distribution of protocols

nAudit preparation like WHO, TGA, MCA, USFDA, ANVISA, ISO etc.

nExposure to Internal Audit and external and preparation of audit report

nDevelop, communicate & adhere to best Testing practices to ensure that no non-conforming batch leaves Company premise

nEnsure optimum utilization of resources available so as to comply with agreed timelines with customers- internal & external

EXECUTIVE HIGHLIGHTS

nAttended USFDA Audit 8 Times in Lupin Pharma Ltd., Aurobindo Pharma Ltd and Dr. Reddy’s

nSuccessfully handled several regulatory inspections such as USFDA, Medicines and Healthcare products Regulatory Agency (MHRA), WHO-Geneva, ANVISA, FIMEA- Finland (NAM), TGA NDA-Uganda WHO India and GCC among others

nHistory of having handled customer audits for prestigious names including Pfizer, GSK, Sandoz, Baxter, North Star, Sanofi-Aventis, Orion, Teva, Sagent, AstraZeneca and many more

nActively involved in Preparation of audit response of USFDA (7 times), FIMEA/MHRA, (5 times), ANVISA (4 times), WHO (Geneva), TGA, NDA and many more and got the approval for the same

nCoordinated, completed & implemented Sterility assurance assessment project with GMP consultant- Quantic, Lachman - USA

nHold the distinction of setting of Risk assessment processes in Aurobindo and Lupin from a scratch

nPerformed formal risk assessment of the site including Facility, Process, Equipment and Water system etc. by incorporating various risk assessment tools

nManaged the Contract Manufacturing Operations site for DSM Sinochem Pharma India Pvt Ltd.

nHandled project of dry powder injections, Including HVAC and water system in Wockhardt, Nectar life sciences and Lupin Ltd

PROFESSIONAL OVERVIEW

Dr. Reddy’s Ltd. May 16- Present

Associate Director–QC/QA (Microbiology)

Spearheading QA/QC functions for 2 units. The plant is an Export Oriented Unit (EOU), with approval of multiple regulatory agencies. This facility is engaged in the manufacturing of injectable (Lypho and TS) and OSD product.

Role Transition:

nLead Microbiology and Sterility Assurance functions for FTO 7 and 9, while spearheading the Validation team for the novel drug product validation related to microbiology. Led the sterility assurance team for injectable facility

nMoved to Baddi site FTO6 & 8 for heading microbiology section, directed entire QC function and led site Compliance & Audits

Key Accomplishments:

nManaged the QC team for Baddi site and defined processes for seamless Compliance & Management of Regulatory Audits

nMet the requirement of regulatory audits for the state-of-the-art facility and handled entire documentation

nRe-designed the existing Quality processes and re-defined the team structure, with clearly defined roles to optimally utilize resources & enable them to deliver in exemplary manner

nHandled the Audits for the site and handled the manpower for facing the audit

nDeep dived into existing ways-of-working and processes, identified gaps as well as areas of improvement and delivered unprecedented process improvement other than successfully managing additional activities

nReduced redundant activities significantly and reduced the EM activity to 50%, also successfully dedicating 20% of manpower for the additional activity

DSM Sinochem Pharmaceuticals India Pvt. Ltd. Dec 13- May 16

Manager QA & GMP

Was responsible to identify the CMO site and subsequently manage Quality Assurance/Quality Control activity for the site for manufacturing of the sterile APIs Penicillinase antibiotics.

nShouldered end-to-end responsibility for Quality Assurance/Quality Control activities for the Contract Manufacturing Operations involving manufacturing sterile APIs Penicillinase antibiotics

Key Accomplishments:

nOvercame the challenging activity that entailed Site selection, while performing Due Diligence and ably conducting Audits & Compliance checks for the site

nHandled the validation activity for the site instrument equipment; conducted process validation for 5 injectable products and assessed shelf life of the product along with driving the cleaning validation study

nConducted the WHO GMP audit for the site

nSuccessfully faced all customer audits during the tenure

nAssured the site for the sterility assurance level and managed the site for required validation as per the regulatory requirement

Aurobindo Pharma Ltd., Hyderabad May 10- Dec 13

Senior Projects

Performed critical activities in the capacity of HOD for the Microbiology Department, with entire accountability of Compliance.

nHandled the critical project for ensuring readiness for the USFDA audit and other regulatory audit preparedness

oPlayed a pivotal role in overall compliance for the audit observation; conducted CQA audit for another site and handled compliance initiatives in close consultation with Lachman consultant

Lupin Pharma Ltd. Bhopal as Manager Feb 08- May 10

Nectar Life sciences Ltd. Chandigarh as Deputy Manager Sep 03- Jan 08

Wockhardt Ltd, Ankleshwar as Senior Microbiologist Aug 01- Sep 03

Aarti Drugs Ltd, Boisar as QC Officer Aug 00- Aug 01

Gujarat Themis Biosyn Ltd, Vapi as QC Officer Jan 99- Jul 00

Jain Foods and Chemicals Ltd, Jalgaon as Microbiologist May 96- Dec 98

PROFESSIONAL DEVELOPMENT PROGRAM

n3 days training on how to face regulatory audits by Stewart Devonport (EX-USFDA Inspector) and Linda Calhon

n2 days workshop on Risk assessment/management

n2 days Auditor Certification training for ISO9001-2008 by NQA

CREDENTIALS

Master’s Degree in Science (Biochemistry) from North Maharashtra University, Jalgaon

Bachelor of Science (Microbiology) from Pune University. Pune

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