SAGAR N. SATPUTE
Pune
Summary
As a seasoned M Pharma. post-graduate with about 11 years of expertise in Quality Operations within the pharmaceutical sector, my background is steeped in valuable experiences with renowned industry leaders. I bring proficiency in Investigation and Compliance, adept Market Complaints Management, strategic Quality Management Systems implementation, seamless IPQA Operations, and a track record of successful team leadership. Certified as both an internal and external auditor, I am now enthusiastic about exploring new professional avenues, ready to apply my proven skills and contribute to the success of a forward-thinking organization in the dynamic pharmaceutical landscape.
Overview
12
12
years of professional experience
Work History
Senior Executive
Centaur Pharmaceutical Ltd.
Pune
10.2022 - Current
- Responsible for the independent review of all site investigations, such as market complaints, deviations, and failure investigations, for their appropriateness as per regulatory requirements.
Executive, Investigation and Compliance
Glenmark Pharmaceutical Ltd.
Goa
10.2016 - 10.2022
- Proficient in the management of market complaints and associated samples
- Diligent follow-up for additional information, ensuring thorough investigations and timely closure of complaints for OSD, SSD facility, and prompt response submission
- Conducted FAR/Rapid alert assessments and meticulously inspected reserve and complaint samples
- Reviewed APQR/Stability Data/Change control/Incident/ Deviation/OOS/OOT documents as part of comprehensive complaint investigations
- Monitored and ensured the effective implementation of CAPA in response to market complaints
- Conducted trending and evaluation of market complaints on a monthly, quarterly, and annual basis
- Played a pivotal role in identifying lead and lag indicators, conducting gap analyses to minimize market complaints
- Contributed significantly and faced regulatory audio like i.e
- USFDA/MHRA
Senior Officer, QA
Cipla Ltd.
Goa
07.2014 - 09.2016
- Involved in IPQA operations across dispensing, manufacturing, and packing stages for oral solid dosage forms
- Conducted thorough reviews of BMR & BPR post-batch completion, establishing a meticulous approach to quality assurance
- Drafted standard operating procedures for shop floor activities, ensuring adherence to cGMP/ALCOA principles
- Analyzed and calibrated IPQA instruments, maintaining detailed logbooks
- Administered comprehensive oversight of deviations, change control, and incidents, ensuring prompt closure and adherence to procedures, showcasing a commitment to operational excellence and product quality
QA Chemist
BHD Industries
Mumbai
07.2012 - 06.2014
- Executed precise IPQA operations across all phases of dispensing, manufacturing, and packing in oral solid dosage forms
- Conducted comprehensive review of BMR & BPR post-batch completion, ensuring quality assessments
- Played a crucial role in critical process data collection, providing vital support to the APQR team for thorough data analysis
- Administered and oversaw all IPQA activities on the shop floor, ensuring stringent compliance with procedural and cGMP requirements
Education
M. Pharma - Pharmaceutics
Shivaji University
Kolhapur09.2012
B. Pharmacy -
Bharati Vidyapeeth
Kolhâpur09.2010
Skills
- Fast Learner
- Leadership
- Ability to Work Under Pressure
- Communication Skills
- Microsoft Excel
- Microsoft Office
References
- Mr. Anand Pathane, Centaur Pharmaceuticals Ltd., Anand.Pathane@yahoo.com, 9552826749
- Mr. Rajiv Bhardwaj, Glenmark Pharmaceuticals Ltd., 9816644381
Extracurricular Activities
Selected In Prestigious President Club Member, Glenmark Ltd., Goa, Goa, 01/01/19, 12/31/20, Based on performance, technical skill and internal exams, selected as Prestigious President Club Member for succeeding two years.
Hobbies and Interests
- Cycling
- Trekking
- Swimming
- Reading
Languages
- English
- Hindi
- Marathi
Personal Information
- Date of Birth: 02/18/88
- Nationality: Indian
Timeline
Senior Executive
Centaur Pharmaceutical Ltd.
10.2022 - Current
Executive, Investigation and Compliance
Glenmark Pharmaceutical Ltd.
10.2016 - 10.2022
Senior Officer, QA
Cipla Ltd.
07.2014 - 09.2016
QA Chemist
BHD Industries
07.2012 - 06.2014
M. Pharma - Pharmaceutics
Shivaji University
B. Pharmacy -
Bharati Vidyapeeth
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