Vinodbabu Mamidibathula
Hyderabad
Summary
Experienced Head of Quality with a proven track record in overseeing quality assurance departments, developing effective strategies, and implementing robust quality control programs. Demonstrates strong leadership skills, fostering team collaboration and instilling a culture of continuous improvement. Notable achievements include improving product quality, enhancing customer satisfaction, and reducing operational inefficiencies. Successfully handled global regulatory inspections.
Overview
34
34
years of professional experience
1
1
Certification
Work History
Freelance GMP Consultant
VB GMP Consultants / Lachman Consultant Services
HYDERABAD
04.2023 - Current
- Contracted with Lachman consultants for assisting with remediation efforts in preparation for FDA re-inspection for an injectable site in India.
- Performing GMP audits, reviews of investigations and CAPAs, facility designs, and regulatory compliance for clients.
Senior Vice President Quality & Compliance
Zenaara Pharma Private Limited
10.2021 - 04.2023
- Responsible for Quality Operations across R&D, Formulation sites ensuring compliance with USFDA & other major regulatory guidance.
Consultant
Self employed
06.2020 - 09.2021
- Consultant for companies in designing facility and drafting Quality Management Systems.
Vice President Corporate Quality
Glenmark Pharmaceuticals Limited
05.2016 - 05.2020
- Led Quality Control and Quality Assurance operations, responsible for investigation of Market complaints across multiple sites.
Associate Vice President Quality
Mylan Laboratories Limited
02.2011 - 04.2016
- Handled a large IPQA team, accountable for QMS events and ensuring compliance with Health Authority regulations.
General Manager QA
Aurobindo Pharma Limited
12.2005 - 01.2011
- Responsible for Quality Operations for major formulation sites, involved in facilities expansions and regulatory audits.
Senior Manager
Hetero Drugs Limited
12.2004 - 11.2005
- Led the Green field project, responsible for project execution and quality support for manufacturing initiatives.
Manager – QA
Aurobindo Pharma Limited
09.2003 - 11.2004
- Joined as Validation Lead, promoted to QA Manager, responsible for compliance and quality assurance operations.
Manager – QA (for Green Field project)
Emcure Pharmaceutical Limited
08.2002 - 08.2003
- Responsible for reviewing and approving Qualification and Validation Protocols, developed Quality Management Systems.
Senior Executive – QA
Parke Davis (Now Pfizer)
12.1994 - 07.2002
- Qualified as a Vendor Auditor, responsible for audits of API Vendors and implementation of Quality Assurance processes.
Analyst
Pharmanalyists
06.1990 - 11.1994
- Performed analysis of raw materials and finished products, conducted laboratory investigations and calibrations.
Education
M.Sc. - Chemistry
Andhra University
Vizag, AP05.1988
B.Sc. - Chemistry
The Hindu College
Machilipatnam, AP05.1985
Skills
- Quality Management
- Process Design
- Compliance Management
- Problem-Solving Acumen
- Team Leadership
- Strategic Team Cohesion
- Drug Product Manufacturing
- Quality Management Systems
- Global Regulatory Requirements
- Validation Principles
- Documentation Compliance
- Supplier Auditing
- Supply Chain Management
- Training on c-GMP
- Investigations
Certification
Statistical Quality Control, Indian Institute of Statistics, 1997
Accoladesandachievements
- Implemented a Quality Council for compliance improvement
- Led multiple process improvement projects
- Key member in launching commercial Generic Products
Leadership Experience
- Developed organizational strategies for GMP compliance
- Mentored and led the Quality Team
- Created talent pipeline and succession plans
Languages
Telugu
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
References
References available upon request.
Timeline
Freelance GMP Consultant
VB GMP Consultants / Lachman Consultant Services
04.2023 - Current
Senior Vice President Quality & Compliance
Zenaara Pharma Private Limited
10.2021 - 04.2023
Consultant
Self employed
06.2020 - 09.2021
Vice President Corporate Quality
Glenmark Pharmaceuticals Limited
05.2016 - 05.2020
Associate Vice President Quality
Mylan Laboratories Limited
02.2011 - 04.2016
General Manager QA
Aurobindo Pharma Limited
12.2005 - 01.2011
Senior Manager
Hetero Drugs Limited
12.2004 - 11.2005
Manager – QA
Aurobindo Pharma Limited
09.2003 - 11.2004
Manager – QA (for Green Field project)
Emcure Pharmaceutical Limited
08.2002 - 08.2003
Senior Executive – QA
Parke Davis (Now Pfizer)
12.1994 - 07.2002
Analyst
Pharmanalyists
06.1990 - 11.1994
Statistical Quality Control, Indian Institute of Statistics, 1997
M.Sc. - Chemistry
Andhra University
B.Sc. - Chemistry
The Hindu College
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