JEEVAN SIDRAM BHADRE
Ahmedabad
Summary
Performance-driven leader with 21 years of experience in quality control, quality assurance, and internal audits in oral solid dosage formulations, with strong analytical and problem-solving capabilities, and passionate about team building in the workplace.
Equipped with strong problem-solving abilities, a willingness to learn, and excellent communication skills. Poised to contribute to team success, and achieve positive results. Ready to tackle new challenges and advance organizational objectives with dedication and enthusiasm.
Overview
21
21
years of professional experience
1
1
Certification
Work History
DGM, Head Global Data Integrity Cell and QUEST
Zydus Lifesciences Limited
Ahmedabad
01.2022 - Current
- Leading the Global Data Integrity Cell and QUEST, consisting of 35 team members, and governing the Data Integrity governance program and QUEST program across the 23 sites of Zydus Group. The sites include 16 formulation sites (11 regulatory and 5 domestic and semi-regulated sites) and 5 regulatory API manufacturing sites.
- Driving the data integrity governance program and QUEST program to ensure that there are no observations related to data integrity violations found during regulatory audits and internal audits, due to systemic controls.
- QUEST (Quality Excellence by Sustainable Transformation): A program to make sustainable change in mindset toward a quality culture.
- Performing the scheduled and unscheduled data integrity audits at sites of Zydus Group.
- Verification of the implementation and effectiveness of CAPA proposed in compliance with inspection observations and routine observations found by the team.
- Effectively facilitating the implementation of 21 CFR Part 11/EU Annexure 11 compliance requirements and data security of laboratory and manufacturing systems at 23 sites.
- Reviewing the data integrity risk assessments of instruments, equipment, and software for quality control, manufacturing, packing, utility, paper systems, and quality-related processes.
- Mitigated risks proactively by conducting thorough analyses of potential threats.
- Review site investigations related to data integrity to identify the root causes, and propose corrective and preventive actions to avoid.
- Gap assessment of FDA 483 and warning letters, and effective implementation of procedures to avoid such observations in the organization.
- Actively participating and providing necessary support in the audit readiness of sites.
- Training and mentoring team members on data integrity detection techniques and findings.
- Currently working on the reduction of equipment cleaning failures and strengthening the equipment cleaning processes in manufacturing to avoid cross-contamination and regulatory observations across the sites.
- Ensured compliance with relevant regulations by developing robust policies and procedures.
- Presenting the monthly performance of the team to senior management.
Senior Manager, Lab Compliance (CQA)
Aurobindo Pharma Limited
Hyderabad
07.2015 - 01.2022
- Led a team of 10 direct reportees and 20 indirect reportees to ensure that the electronic data generated in the quality control laboratory of 12 formulation sites is in compliance with the current regulatory requirements.
- Effectively directed the review of laboratory investigations (OOS, OOT, non-conformances), including breaches of data integrity, to identify the root causes and propose corrective and preventive actions to avoid.
- Performed the internal audits for Quality Control laboratories of formulation sites of the Aurobindo Group.
- Performed a gap assessment of FDA 483 and warning letters, and effective implementation of procedures to avoid such observations in the organization.
- Effectively directed the periodic review of audit trails of enterprise software and laboratory instruments involving audit trail events, user management, data backup, restoration activity, password security policy, data protection, 21 CFR Part 11/EU Annexure 11 compliance requirements, and data security of laboratory systems of formulation sites.
- Harmonized laboratory systems and quality control common procedures for formulation sites and their implementation.
- Actively participated and provided necessary support in regulatory audits for quality control laboratories of formulation sites.
- Acted as an SME for Empower and standalone software for formulation sites.
Assistant Manager, Level-5, Quality Control
Sanofi India Limited
Goa
08.2009 - 06.2015
- Led a team of 12 reportees in the finished product section and ensured the timely release of the product batches to meet market requirements.
- Review of laboratory investigations, such as out of specifications, out of trends, deviations, and chromatographic errors.
- Performed analysis and review of finished products, in process, process validation, and stability samples (tablets and capsules).
Senior Officer, Quality Control
Watson Pharma Private Limited
Goa
12.2006 - 07.2009
- Led a team of 5 reportees and ensured that the laboratory instruments and equipment were in a qualified and calibrated state, with minimal breakdown.
- Ensured the on-time availability of resources such as Working Standards, Reference Standards, Primary Standards, volumetric solutions, and test solutions required for analytical activities for smooth business operations.
- Played a key role in the expansion of the Quality Control laboratory.
Officer, Quality Control
Lupin Limited
Goa
06.2004 - 12.2006
- Performed analysis of Finished product, In process samples, Process validation samples and Stability samples of generic drug products (ANDA).
- Performed Scheduled/Unscheduled Calibration and maintenance of laboratory instruments and equipment.
- Maintained Working Standards, Reference Standards, Primary Standards, Calibration Standards, Volumetric Solutions and Test solutions.
Education
Master of Science - Analytical Chemistry
SHIVAJI UNIVERSITY
KOLHAPUR04-2004
Bachelor of Science - Chemistry
SHIVAJI UNIVERSITY
KOLHAPUR04-2002
Skills
- Audit and compliance
- Quality control
- Quality assurance
- Quality management system
- Data integrity
- Audit trails
- Investigations
- Risk assessment
- Computerized system validation
- Security controls on GxP systems
- Leadership and team building
- USFDA, MHRA, WHO
Accomplishments
Recognized as Emerging Leader of the Year 2023 at Zydus Lifesciences Limited
Certification
- FDA approval in Chemical and Instrumental Analysis of Drugs by Indian FDA : Mar-2012
- Lean Six Sigma Master Black Belt by Henry Harvin Education : Jun-2021
- Lean Six Sigma Black Belt by Henry Harvin Education : Feb-2021
Languages
Marathi
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
kannada
Intermediate (B1)
B1
References
References available upon request.
Timeline
DGM, Head Global Data Integrity Cell and QUEST
Zydus Lifesciences Limited
01.2022 - Current
Senior Manager, Lab Compliance (CQA)
Aurobindo Pharma Limited
07.2015 - 01.2022
Assistant Manager, Level-5, Quality Control
Sanofi India Limited
08.2009 - 06.2015
Senior Officer, Quality Control
Watson Pharma Private Limited
12.2006 - 07.2009
Officer, Quality Control
Lupin Limited
06.2004 - 12.2006
Master of Science - Analytical Chemistry
SHIVAJI UNIVERSITY
Bachelor of Science - Chemistry
SHIVAJI UNIVERSITY
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