Gourav Gaonkar
Manager
Goa,MH
Summary
Experienced pharmaceutical quality expert with a proven track record in ensuring compliance with regulatory standards, including cGMP, FDA regulations, ICH guidelines, and EU GMPs. Skilled in developing and managing Quality Management Systems (QMS) to improve operational efficiency and product quality. Proficient in supplier management and vendor qualification, fostering seamless collaboration and high-quality partnerships. Adept at auditing compliance and ensuring adherence to regulatory expectations. Demonstrated proficiency in handling electronic systems and a strong commitment to data integrity, ensuring compliance with regulatory requirements.
Overview
14
14
years of professional experience
6
6
years of post-secondary education
4
4
Languages
Work History
Manager
Ernst & Young LLP
01.2024 - Current
- Managed key projects in the Goa region as Project Manager, focusing on equipment qualification and Computerized System Validation (CSV) using waterfall and agile methodologies
- Ensured adherence to rigorous industry standards and regulatory requirements, demonstrating meticulous project management and coordination with cross-functional teams to maintain the highest quality and compliance standards
- Guided the team to design and develop Software Development Lifecycle Documents (SDLC) as per the client procedures and requirements
- Reviewed SDLC documents to ensure that they adhere to good documentation practices and are prepared as per Good Engineering Practices
- Led SAP S/4 HANA qualification projects, enhancing system efficiency with targeted configuration, testing, and validation efforts
- Directed digital quality transformation initiatives, achieving enhanced compliance through innovative digitalization strategies
- Designed and implemented vendor management programs, leading teams in vendor onboarding and qualification processes to enhance supply chain integrity
- Served as a subject matter expert for cGMP, QMS, CSV, GAMP5, and 21 CFR Part 11, providing critical guidance to clients on regulatory requirements
- Offered specialized knowledge in validation strategies, ensuring consistent compliance with quality and regulatory standards, and partnered with global clients to mitigate operational risks
- Drove Commissioning, Qualification, and Validation (CQV) projects for new pharmaceutical manufacturing facilities, demonstrating hands-on leadership
- Created and delivered customized training programs on Data Integrity, Computerized System Validation, and GAMP 5, educating a diverse professional audience
Deputy Manager
Indoco Remedies Limited
12.2019 - 01.2024
- Championed the role of Project Lead for the Computer System Validation (CSV) Team, steering multiple digitalization initiatives that were pivotal to the organization's Digital Transformation strategy
- Directed the organization-wide implementation of TrackWise Quality Management System (QMS) software as the Project Lead, significantly boosting quality compliance and process standardization across all sites
- Orchestrated the deployment of a Document Management System (DMS) for Standard Operating Procedures (SOPs) and regulatory documentation, showcasing strong project governance and attention to regulatory adherence
- As a Core Team Member and Project Contributor for the SAP S/4 HANA rollout, I was instrumental in the creation of Computer System Validation (CSV) documentation and risk assessments, ensuring project deliverables met the highest standards
- Developed and executed comprehensive training programs for over 200 end-users on new software systems, exemplifying strong project management in user adoption and change management
- Proficiency in vendor audits
- Served as Lead Auditor for 30+ vendor audits across raw materials, APIs, and packaging material vendors
Executive Quality Assurance
Tevapharm India Pvt. Ltd.
07.2016 - 12.2019
- Effectively managed Change Control processes, maintaining close coordination with cross-functional teams to ensure timely approvals and implementation, thereby minimizing disruptions and ensuring continuous compliance with quality assurance protocols
- Successfully managed vendor qualification activities, ensuring that all vendor submissions met stringent corporate quality standards and regulatory requirements, thereby enhancing supplier reliability and compliance
- Developed robust tracking systems for CEP/DMF updates, ensuring compliance with EU regulatory requirements
- Reviewed batch records, CAPA reports, and stability protocols to ensure alignment with regulatory commitments
Officer Regulatory Affairs
Encube Ethicals Pvt. Ltd.
11.2014 - 07.2016
- Conducted 45+ On-Site Vendor Audits for Raw Materials and Packaging Materials, preparing detailed reports and driving closure of audit findings
- Ensured vendors met all qualification standards for APIs, excipients, and packaging materials
- Drafted and maintained annual audit schedules, facilitating smooth execution of the audit lifecycle
Officer Quality Assurance
Abbott India Limited
04.2013 - 11.2014
- Oversaw the overall Quality Management System, including the evaluation of change controls, active participation in deviation investigations, and the identification and implementation of CAPA
- Performed daily release of batches in SAP after review of Batch Records and ensuring all the observations are complied with
- Participated in implementation of TrackWise
- Performed 20+ vendor audits and managed the documentation and reporting cycle for compliance
- Drafted audit reports, coordinated with the vendors for compliance reports and ensured all the audits were closed within the stipulated time period
- Coordinated self-inspection schedules, identifying areas for operational improvement
Officer Quality Assurance
Cadila Healthcare Limited
01.2011 - 04.2013
- Managed equipment qualification for tablet and injectable manufacturing facilities
- Conducted Process Validation Activities, contributing to improved product quality
- Maintained price list for domestic products ensuring that only correct prices were printed on the products
Education
Master of pharmacy -
Goa University
01.2008 - 01.2010
Bachelor of pharmacy - undefined
Goa University
01.2004 - 01.2008
Training Certificate - undefined
Indian Leadership Academy
Skills
Data Integrity
Quality Assurance
Quality Management Systems (QMS)
Change Management
CAPA
Computerized System Validation (CSV)
Good Manufacturing Practices
GAMP 5 compliance expertise
21 CFR Part 11 knowledge
Vendor Audit
Accomplishments
- Supervised team of 6 staff members and successfully led the organization of the journey to digitalization.
- Successfully led CSV team for implementation of SAP S/4 HANA
- Successfully implemented TrackWise, DMS and LIMS throughout the organization
Timeline
Manager
Ernst & Young LLP
01.2024 - Current
Deputy Manager
Indoco Remedies Limited
12.2019 - 01.2024
Executive Quality Assurance
Tevapharm India Pvt. Ltd.
07.2016 - 12.2019
Officer Regulatory Affairs
Encube Ethicals Pvt. Ltd.
11.2014 - 07.2016
Officer Quality Assurance
Abbott India Limited
04.2013 - 11.2014
Officer Quality Assurance
Cadila Healthcare Limited
01.2011 - 04.2013
Master of pharmacy -
Goa University
01.2008 - 01.2010
Bachelor of pharmacy - undefined
Goa University
01.2004 - 01.2008
Training Certificate - undefined
Indian Leadership Academy