Mahesh Patil
Dhule
Summary
Experienced pharmaceutical quality professional with 17 years of expertise in Computer System Validation (CSV) and Quality Management Systems (QMS). Experienced in leading validation activities throughout the System Development Life Cycle (SDLC), ensuring compliance with cGMP, GAMP 5, and 21 CFR Part 11 requirements. Skilled in managing Change Controls, Deviations, CAPA, and quality documentation to drive continuous quality improvement, regulatory compliance, and data integrity.
Overview
17
17
years of professional experience
Work History
Manager -QA (AMV, CSV, CMC & QMS)
Nevakar Pharmaceuticals
New jercy
02.2021 - Current
- Evaluated Analytical Method Validation (AMV) documents, such as validation protocols, reports, lab notebooks, and raw data (chromatograms) for diverse drug substances and drug products, focusing on assay, related substances, residual solvents, and dissolution.
- Reviewed and approved System Development Life Cycle (SDLC) documentation to ensure compliance and quality standards.
- Expertise in applying a Risk-Based Approach to Computerized Systems Validation leveraging GAMP 5 methodologies to optimize life-cycle testing and validation efforts.
- Develop,review, and approve validation deliverables including System Impact Assessments (SIA/GxP), User Requirement Specifications (URS), Validation Assessments (VA), Validation Plans, 21 CFR Part 11 assessments, Design Specifications (HDS/SDS/FDS),Risk assessments (FMEA), functional risk assessments, Testing Protocols (IQ/OQ/PQ/UAT) and Requirements Traceability Matrices (RTM).
- Conduct audits and comprehensive reviews of all CMO (Contract Manufacturing Organization) documentation
- Executed change control processes in laboratory to ensure adherence to quality system standards and regulatory requirements.
- Review and evaluate analytical data and related activities initiated at CMO sites to ensure compliance and accuracy.
- Oversaw QMS activities, including OOS and OOT, to support timely product release and maintain compliance.
- Periodically review and verify maintenance schedules, equipment/instrument calibrations, incident closures, and change control documentation
- Collaborate with Nevakar Regulatory team to ensure documentation is complete and compliant for NDA submissions.
- Review and approve specifications, standard testing procedures, and standard operating procedures (SOPs).
- Monitor timelines and ensure adherence to approved Quality Agreements.
Sr. Executive- (Lab QA)
Wockhardt Ltd
Aurangabad
05.2015 - 02.2021
- Oversaw the management and review of analytical raw data for finished products, raw materials, in-process samples, stability samples, and calibration records of laboratory instruments.
- Conducted reviews and approvals of specifications, standard testing procedures (STPs), standard operating procedures (SOPs), stability protocols, stability summary reports, annual product reviews (APR), and certificates of analysis for finished products.
- Ensured GLP compliance and managed QMS documentation, including change controls, CAPAs, deviations, OOS, OOT, OOC, training records, and timely release of finished products to support regulatory adherence and product quality.
- Executed Computer System Validation (CSV) for Chromoline Chromatography Data System (CDS) software, ensuring regulatory compliance while conducting stability testing, monitoring instrument calibration, tracking chemical usage, and overseeing water trend analysis to maintain operational integrity.
- Perform periodic and post-implementation reviews of GxP systems in accordance with the site validation Master Plan/SOPs.
- Supported operations at USFDA-approved sterile injectable manufacturing facility, recognized for advanced infrastructure and global regulatory compliance, enabling high-throughput operations for regulated markets including US, EU, and ROW.
Research Executive in ADL
SAI Life Science
Pune
07.2014 - 05.2015
- Facilitated drug development and manufacturing for regulated markets and aligned analytical development with international regulatory standards.
- Executed literature searches, managed technology transfer, and conducted lab round inspections to ensure GLP compliance.
- Collaborated with the regulatory team for CMC documents.
- Oversaw stability and retention sample management to ensure regulatory compliance and support analytical processes.
- Supported quality management system activities to ensure adherence to industry standards.
- Conducted method development, validation, and troubleshooting.
- Performed cleaning method validation, stability analysis, R&D studies, and documentation.
- Analyzed R&D batches during pre-formulation studies.
- Routine analysis of finished products.
- Performed calibration of instruments to maintain precision in experimental processes.
- Conducted joint analysis and method validation at manufacturing sites.
Research Analyst in ADL
USV Ltd.
Govandi Mumbai
10.2013 - 07.2014
- Developed and validated analytical methods to enhance accuracy and reliability.
- Stability study analysis of drug product, drug substances, excipient compatibility study, photo stability study.
- Documentation of Stability and finished products as per cGMP.
- Executed R&D batch studies to meet pre-formulation specifications.
- Responsible for performing root cause analysis.
- Troubleshot instruments to identify and resolve malfunctions.
- A research-driven pharmaceutical company known for its expertise in generics, biosimilars, and branded formulations.
Sr. Analyst in ADL
Indoco Remedies
Rabale, Mumbai
01.2011 - 10.2013
- Contributed to method development, validation, and technology transfer to ensure compliance and reliability.
- Conducted routine analysis of finished products to maintain quality standards and regulatory compliance.
- Stability study analysis of drug product, drug substances, excipient compatibility study, photo stability study.
- Documented stability studies and finished products per cGMP to ensure traceability and regulatory adherence.
- Developed and validated cleaning methods.
- Calibrated laboratory instruments to ensure accurate measurements.
- Troubleshot instruments to resolve technical issues.
- A well-established pharmaceutical company with a strong presence in generics, APIs, and formulations for regulated markets.
Junior officer in QC
IPCA Laboratories ltd.
Silvassa
06.2009 - 10.2010
- Performed analysis of finished products, stability, and intermediate samples to ensure compliance with quality standards.
- Conducted analysis of cleaning verification and cleaning validation to support product safety and quality assurance.
- Executed routine quality control tasks in lab, maintaining product integrity and safety through thorough documentation including lab notebook and raw data (chromatograms) for various drug substances and products.
- WHO-GMP and USFDA-approved facility specializing in the manufacturing of APIs and finished dosage forms.
Education
M.Sc - Analytical Chemistry
P.O. Nahata college
Bhusawal, Dist Jalgoan01-2009
B.Sc -
Jai Hind College
Dhule, Dist Dhule01-2007
Skills
- Computerized systems validation
- Method validation
- Quality management
- Regulatory adherence
- Change control management
- Risk analysis
- Root cause analysis
- Project planning
- Time management
Audits Performed And Faced
- WHO-GMP
- FDA
- HPRA
- MHRA
Disclaimer
I Mahesh Patil, hereby state that the information compiled above is precise and accurate in its entirety to the best of my knowledge.
Basic Information
M.Sc (Analytical Chemistry), 17 Years (R&D, QC, QA, Injectable, OSD & Biotech formulation), US based 'Nevakar pharmaceutical's, Manager -QA (CSV, AMV, CMC & QMS) Hybrid / Remote profile.
Personal Information
- Notice Period: 3 Months
- Date of Birth: 09/04/86
- Gender: Male
- Marital Status: Married
Timeline
Manager -QA (AMV, CSV, CMC & QMS)
Nevakar Pharmaceuticals
02.2021 - Current
Sr. Executive- (Lab QA)
Wockhardt Ltd
05.2015 - 02.2021
Research Executive in ADL
SAI Life Science
07.2014 - 05.2015
Research Analyst in ADL
USV Ltd.
10.2013 - 07.2014
Sr. Analyst in ADL
Indoco Remedies
01.2011 - 10.2013
Junior officer in QC
IPCA Laboratories ltd.
06.2009 - 10.2010
M.Sc - Analytical Chemistry
P.O. Nahata college
B.Sc -
Jai Hind College