Sumit Shelar
Bengaluru
Summary
10+ Years of Experience Microbiologist with demonstrated history of working in the pharmaceuticals industry. Strong research professional, skilled in aseptic techniques, Good Laboratory Practice (GLP), and Good Manufacturing Practices (GMP).
Overview
8
8
years of professional experience
Work History
Assistant Manager AQA
Biocon Biologics Ltd
Bengaluru
04.2023 - Current
- Complete review of QMS elements such as Deviations, Change control, OOAC, OOAL,OOS, Laboratory Incident, Risk assessments and closure in trackwise application.
- Responsible for conducting shop floor inspections of QC laboratory and provide observations if any to comply as per regulatory requirements.
- Review and approval of consumables, packaging materials, raw materials in LIMS and SAP.
- Review of raw data of in-process batches, conducting audit trials of UV and osmolality and batch release activities.
Junior Executive
Indoco Remedies Ltd
Goa
05.2021 - Current
- Lead Investigations for deviations, environmental excursions and laboratory Incidents.
- Determine root cause, implement corrective and preventive actions (CAPA) and conduct effectiveness checks.
- Ensure timely closure of QMS documents in line with regulatory requirements.
- Facilitate and manage cross functional teams (CFT) discussions to address and resolve observed discrepancies.
Senior Officer (QA)
Marksans Pharma Ltd
Goa
07.2018 - 05.2021
- Ensure overall compliance with quality assurance standards in the QC Microbiology laboratory.
- Supervise and monitor the implementation of good laboratory practices (GLP) standard operation procedures and regulatory requirements.
- Active participation in investigations and root cause analysis related to laboratory errors, test failures and non-conformances.
- Supervise and review of microbial identification reports generated using the vitek2 compact system.
Senior Executive
Cipla Limited
Goa
09.2017 - 05.2018
- Responsible for maintenance of master cultures of standard organisms.
- To perform identification of isolates using vitek 2 compact systems (Make -Biomerieux), and API identification Kit (Make -Biomerieux).
Quality Control Officer
Emcure Pharmaceuticals Ltd.
Pune
09.2017 - 05.2018
- Conducted comprehensive environmental monitoring utilizing both active and passive air sampling techniques.
- Performed water sampling and microbiological analysis using membrane filtration and pour plate methods in accordance with standard operating procedures.
- Prepared culture media and executed growth promotion testing with standardized microorganisms (Bio Ball) to ensure media suitability and quality compliance.
Education
M.Sc. - Microbiology
Modern College
Pune01.2014
B.Sc. - Microbiology
Modern College
Pune01.2012
HSC (PCMB) -
Bhairavnath Jr College
Bhosari Pune01.2009
SSC -
Hindustan Antibiotics School
Pune01.2007
Skills
- Environmental monitoring
- Aseptic techniques
- Quality management systems
- Microbial Identification using Vitek 2
- Quality control and assurance
- Disinfectant efficacy testing
- Good laboratory practices
- Document review
Websites
Projects
Master's Dissertation, Isolation and Characterization of Multi drug resistant Micro-organisms from mutha river and Plasmid Curing using herbal extract under the guidance of Dr. Shilpa Mujumdar Head Microbiology Department.
Disclaimer
I hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the authenticity of the above-mentioned particulars.
Audits Faced
- USFDA
- MHRA
- TGA
- ANVISA
- WHO
- HPRA
- EMA
Areas Of Interest
- Document Review
- Pharmaceuticals
- Biopharmaceuticals
Languages
Marathi
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Timeline
Assistant Manager AQA
Biocon Biologics Ltd
04.2023 - Current
Junior Executive
Indoco Remedies Ltd
05.2021 - Current
Senior Officer (QA)
Marksans Pharma Ltd
07.2018 - 05.2021
Senior Executive
Cipla Limited
09.2017 - 05.2018
Quality Control Officer
Emcure Pharmaceuticals Ltd.
09.2017 - 05.2018
M.Sc. - Microbiology
Modern College
B.Sc. - Microbiology
Modern College
HSC (PCMB) -
Bhairavnath Jr College
SSC -
Hindustan Antibiotics School