Quality Systems Innovation, Regulatory Technology, Data Integrity, AI in Pharma
Anand Raghunath Kambli
Pharmaceuticals Quality control and Quality assurance
Sangolda, Morod, Bardez, Goa,Goa
Summary
Accomplished Quality Control & Assurance leader with over 25 years of experience in regulated pharmaceutical environments. Proven expertise in leading large cross-functional teams (100+), managing regulatory inspections (USFDA, MHRA, ANVISA, TGA, WHO), establishing and scaling laboratories, and driving operational excellence through Lean, Six Sigma, and digital systems implementation. Recognized for reducing errors, optimizing processes, and fostering a culture of compliance, innovation, and efficiency.
Overview
25
25
years of professional experience
4
4
Languages
Work History
Associate General Manager
Syngene International Limited
Bengaluru
06.2019 - Current
- Heading overall laboratory quality activities along with GMP and Quality compliances with team size of 85.
- Lead audits and successfully cleared USFDA with Zero 483's & Responsible for lab compliance, regulatory queries and audit responses.
- Client interactions, quality presentations, business enhancements and deliverables.
- Gemba walk, QMS investigations, quality support and technical expertise.
- Budget management, resource management, trainings, schedules, and contract negotiations.
- Successfully completed drive for CSV for all instruments.
- Implementation of LIMS, LMS, EDMS, Trackwise, SAP module.
- Working on Operational excellence projects. Lean, 6 Sigma, greenbelt projects.
- Working on Expansion of labs and chamber facilities.
- Other confidential projects with overall quality responsibilities.
Deputy General Manager
Micro Labs
BENGALURU
08.2018 - 05.2019
- Headed Quality Control for 2 labs (2Nos) for team of 120.
- Handled major Regulatory audits.
- Participated in planning process to achieve corporate objectives.
- Administered operating budget, approved expenditures and implemented budgetary adjustments.
- Introduced new methods, practices, and systems to reduce turnaround time and human errors.
- Collaborated with department heads to establish goals and work plans.
Senior Manager
Apotex Research Pvt Ltd
Bengaluru
12.2015 - 07.2018
- Lead Exhibit Stability lab with team size of 45 people.
- Handled 2 USFDA, MHRA, other Regulatory audits and Involved in US FDA remedial actions.
- Involved lab compliance and submissions for US, EU, Russia and other markets.
- Provided strong leadership to enhance team productivity and morale.
- Instrumental in developing and mentoring and representing the R&D team for Audits.
- Implemented LIMS for Stability lab.
Manager
Glenmark Pharmaceuticals Limited
Colvale, Goa
10.2011 - 12.2015
- Managed QC and QA activities and handled audits like USFDA, MHRA, TGA, ANVISA, MCC, TPD-Canada, Ethiopia, WHO.
- Self-motivated, with strong sense of personal responsibility.
- Demonstrated leadership skills in managing operational projects from concept to completion.
Head Laboratory
Lupin Limited
Verna, Goa
10.2010 - 10.2011
- Managed quality control lab with USFDA and MHRA audits with Zero 483's and all regulatory market's business with respect to submissions and commercial activities.
- Managed activities of Exhibit/ANDA batches fillings and query responses, IP, FP, hold time study, dissolution profile, technology transfers and stability study for products of US, EU, Brazil, SA, and other markets.
- Demonstrated high level of initiative and creativity while tackling difficult tasks.
- Applied effective time management techniques to meet tight deadlines.
Manager-Head Quality
Glenmark Pharmaceuticals Limited
Kundaim, Goa
05.2009 - 08.2010
- Headed quality assurance and quality control for overall functions.
- Managed lab, facility set up, qualifications and readiness of manufacturing unit.
- Driven QA and QC team towards audits and regulatory business.
Assistant Manager Quality
Glenmark Generics Limited
Colvale, Goa
01.2004 - 04.2009
- Managed Quality control and quality assurance activities
- Major contributor in harmonization of procedures throughout all sites of Glenmark.
- Contributed to analysis, planning, reviews and managing people
- Core team member for audits
- SAP implementations project, software upgradations.
- Boosted employee morale by recognizing outstanding performance and celebrating team accomplishments
Quality Control Officer
Abbott India Limited
Verna, Goa
09.2001 - 12.2003
- Inspected incoming materials for adherence to company quality standards, sampling, IPQA, testing and releases.
Education
Master of Science - Chemistry
Goa University
Taligao, Goa 06.1998 - 05.2000
Bachelor of Science - Chemistry
St. Xavier's College
Mapusa, Goa 06.1995 - 05.1998
Skills
Training and development background
Accomplishments
- Contributed to remedial actions and compliances successfully at Apotex.
- QC lab set up for Marksons, Glenmark.
- SAP QM modules implementation for Glenmark.
- Preparation of Validated Excel Sheets for calculation.
- Promoted in Syngene and multiple times in Glenmark..
- Buisness Excellence awards at Glenmark.
- Strong track records in reducing human errors in almost all labs.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Associate General Manager
Syngene International Limited
06.2019 - Current
Deputy General Manager
Micro Labs
08.2018 - 05.2019
Senior Manager
Apotex Research Pvt Ltd
12.2015 - 07.2018
Manager
Glenmark Pharmaceuticals Limited
10.2011 - 12.2015
Head Laboratory
Lupin Limited
10.2010 - 10.2011
Manager-Head Quality
Glenmark Pharmaceuticals Limited
05.2009 - 08.2010
Assistant Manager Quality
Glenmark Generics Limited
01.2004 - 04.2009
Quality Control Officer
Abbott India Limited
09.2001 - 12.2003
Master of Science - Chemistry
Goa University
06.1998 - 05.2000
Bachelor of Science - Chemistry
St. Xavier's College
06.1995 - 05.1998
Interests
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