Vivek Choubharkar
Microbiologist
Latur
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
14
14
years of professional experience
2011
2011
years of post-secondary education
1
1
Certification
3
3
Languages
Work History
Sr. Executive
Macleods Pharmaceutical Ltd
07.2024 - Current
- Coordinated work assignments for microbiology laboratory personnel to optimize workflow and resource allocation.
- Actively participated in microbiology lab installation and qualification.
- Executed protocol preparation to support laboratory processes and maintain regulatory compliance.
- To prepare and review the protocols, SOP, Method validation, IQ, OQ, PQ Protocols.
- Review of all microbiology data and reports.
- Facilitated training for department personnel in microbiology laboratory using PLMS software, enhancing staff competency and compliance.
- Managed investigations of deviations, change controls, OOS, OOAC, and OOAL to ensure regulatory adherence and quality assurance.
Sr. Executive in Lab Quality assurance
Aurobindo Pharmaceutical Ltd
08.2022 - 06.2024
- Oversaw lab operations to ensure compliance with GLP, regulatory standards, and GMP documentation.
- Planned and allocated work to subordinates for execution of daily microbiology lab activities, ensuring operational efficiency.
- To design and maintain training programs for Microbiology staff and production staff as applicable, to ensure compliance with current cGMP requirements.
- Led implementation of safety initiatives in microbiology lab, enhancing workplace safety standards.
- Reviewed calibration of equipment including autoclave, DHS, LAF, biosafety cabinets, incubators, refrigerators, pass box, and water bath in microbiology laboratory, maintaining compliance with schedule.
- Handling of laboratory investigations and completion of deviation reports. Change control management.
- To review Instrument operation & calibration SOPs, laboratory SOPs review, other technical documents like MLT protocols/ reports etc.
- Review of Sampling and analysis (MLT) of raw materials/ packaging materials/ finished dosage forms/ stability testing as per Pharmacopeia.
- Review trending of environmental monitoring data, including water, air & surface, compressed air etc.
- Participated in root cause analysis and proposed preventive maintenance while maintaining plant hygiene practices.
- microbiological activities including Hold time validations and Hold time study.
Executive Lab Quality Assurance
Wockhardt Pharmaceutical Ltd
11.2015 - 07.2022
- Work experience with pharma consultant like Step Change and Quantic consultant for continuous improvement in Microbiology laboratories.
- Work on Master Compliance Action Plan (M-CAP) developed.
- Work in Corporate Quality Assurance department for harmonization of microbiological practices in Wockhardt site through Global change control.
- Resolved deviations, incidents, and excursions.
- Handling of Track wise to raise the change control, deviation and CAPA.
- Review of GLP practices in Microbiology Laboratory.
- Review of documents and SOPs.
- Conducting Unit Operations of different SOPs and practices followed in Laboratory.
- Handling and coordinating of Investigations of OOS, OOAC (Out of Action level) and OOAL (Out of Alert level).
- Handling and coordinating in Deviations.
- Handling of SOP related Change controls.
- Worked as reviewer in Microbiology laboratory.
- Facilitated training programs to enhance compliance with laboratory protocols and procedures.
- Review of daily activities and checked Good Laboratory Practices and Good Documentation practices.
Jr. Executive
Hospira Healthcare Pvt. Ltd
05.2012 - 10.2015
- Executed method validation and conducted MLT for raw materials and finished products, ensuring adherence to harmonized protocols.
- Conducted environmental monitoring using air sampling, settle plate techniques, and surface monitoring to ensure compliance with safety standards.
- Performed area qualification to uphold facility standards and ensure compliance with regulatory requirements.
- Microbial analysis of potable & purified water.
- Preparation of media and performed Growth promotion test, inhibitory test, preincubation check test.
- Trend preparation of water & environmental count data.
- To review standard operating procedures related to various activities.
- Experience of paperless automation system.
Education
M.sc - Microbiology
Skills
Teamwork and collaboration
Flexible and adaptable
Multitasking
Dependable and responsible
Supervision and leadership
Problem-solving
Time management
Team management
Accomplishments
- Handled the team and faced the regulatory audits successfully and compliant.
- Worked in USFDA, MHRA, WHO GMP, TGA Approved plant engaged in the manufacturing Of Sterile and Non sterile products.
Certification
Food and drug administration government of Maharashtra approval Microbiology and sterility test ID MH-6072345
Timeline
Sr. Executive - Macleods Pharmaceutical Ltd
07.2024 - Current
Sr. Executive in Lab Quality assurance - Aurobindo Pharmaceutical Ltd
08.2022 - 06.2024
Food and drug administration government of Maharashtra approval Microbiology and sterility test ID MH-6072345
10-2016
Executive Lab Quality Assurance - Wockhardt Pharmaceutical Ltd
11.2015 - 07.2022
Jr. Executive - Hospira Healthcare Pvt. Ltd
05.2012 - 10.2015
Dr. B.A.M.U Sub Centre - M.sc, Microbiology
Disclaimer
I do hereby declare that the information given above is true and correct to the best of my knowledge.
Personal Information
Languages
- English
- Hindi
- Marathi
Education
M.sc Microbiology Dr.BAMU year 2011