Sheetalben I Agree
Vapi
Summary
Accomplished Senior Manager in Microbiology with a proven track record at USV Laboratories PVT LTD, enhancing GLP and cGMP standards and leading successful software implementations. Expert in cross-functional team leadership and talent development, with significant achievements in regulatory compliance and operational efficiency. Skilled in reporting oversight and corporate communications, demonstrating a confident approach to driving business performance.
Overview
19
19
years of professional experience
Work History
Senior Manager Microbiology (Q.C)
USV Laboratories PVT LTD
Daman
09.2019 - Current
- Continuous improvement of GLP and cGMP standards in the lab and facility, as per the guidelines of the EU, PIC/S, USFDA, Schedule M, and USV Global Corporate guidelines.
- To coach and qualify the microbiologist in critical testing methods.
- To prepare the yearly budget, CAPEX of the laboratory, and adhere to the budget.
- Ensure effective implementation of global compliance observation, regulatory audit, and corporate audit observation of the laboratory.
- To lead in laboratory OOS/OOL – root cause investigation of FG, RM.
- To conduct risk analysis, mitigation plans, and effective implementation action items of global and plant CAPA.
- Ensure the qualification of critical equipment in the plant and lab, microbiological method validations, and laboratory change control.
- Update SOPs, validation protocols, and laboratory documents as per USV global and regulatory requirements.
- To lead and ensure compliance of the laboratory, support manufacturing operations, and engineering utilities in Global Compliance (GC) audit, corporate internal audit, and regulatory audits.
- To implement the Environment, Health, and Safety Policy.
- Plant Facility Sterility Assurance (FSA) representative.
- To support and conduct a market-compliant investigation.
- To support and assist in the development and introduction of new products, environments, and processes.
- Handling of QMS software tools (Trackwise and ETMS) for CAPA, change controls, audits, and vendor approvals.
- To conduct risk analysis for manufacturing processes and equipment, and to implement the risk mitigation plan.
- To conduct training and coaching on basic microbiology for manufacturing personnel and operators.
- Involved in LIMS software implementation.
Deputy Manager Microbiology (Q.C)
Alkem Laboratories PVT Ltd
Amaliya
06.2008 - 09.2019
- Preparation of SOP and Validation protocol for Microbiology department
- MLT method validation by pour plate method and filtration method
- Autoclave, Dry heat sterilizer validation and protocol preparation and equipment qualification
- Review and approval of Water analysis report and MLT reports, media Preparation, Culture maintenance record and other microbiological related documents
- Sterility and Bacterial endotoxin test of raw material and finished product and its method validation
- Isolation, purification and Identification of Microorganisms using VITEK-2 System
- Preparation of protocol for Sanitizer efficacy test, Media Hold time and its implementation
- Handling of out of specification results of microbiology department
- Compliance of audit related to microbiology
- Budget preparation and establishment of new lab for microbiology
Officer - Q.C.
Injectcare Parenteral Pvt. LTD
04.2007 - 06.2008
- Analysis of Potable Water, Purified Water, and Water for Injection for the micro analysis as per SOP
- Analysis of LAL Test for WFI, Finished Products and Raw Materials
- Sterility Test for finished product and raw materials
- Subculture of Micro- organism to be performed as per SOP
- Calibration of biological equipment’s and validation of Autoclave, Incubator, and Dry heat sterilizer as per Validation protocol and SOP
- Environment monitoring by settle plate, contact plate and Air sampling and Personal monitoring
- Microbial limit test of Raw material
OFFICER Q.C.
Umedica Laboratories LTD
Vapi GIDC
08.2005 - 04.2007
- Sampling of raw material, intermediate and finished product for microbiological analysis
- Receiving, storage, issue and preparation of dehydrated microbial culture media
- Disposal of used media, cultures and dehydrated media
- Sampling and microbial analysis of different grades of water
- Sterility and BET test of WFI, Raw material and finished product
- Biological indicator population verification
- Growth promotion test
- Calibration of pH meter, balance and Micropipettes
- Preparation of Microbial inoculums and maintenance of microbial cultures
Education
MBA(TQM) -
IIBPS
M.Sc - Microbiology
Veer Narmad South Gujarat University
B.Sc - Microbiology
Veer Narmad South Gujarat University
12th -
GSEB
10th -
GSEB
Skills
- Reporting oversight
- Business performance management
- Talent development
- Cross-functional team leadership
- Software implementation
- Corporate communications
Auditsfaced
- MHRA – UK
- WHO – Geneva
- Ukraine
- ANVISA
- USFDA
Experienceinfollowingdosageforms
- Solid Dosage form (Tablet & Capsule)
- Parenteral
Languages
- English
- Gujarati
- Hindi
Hobbies and Interests
- Listening music
- Reading
Disclaimer
I hereby declare that all the information given above is true to the best of my knowledge and behalf.
Activities
- Operating of LIMUS related to QC Microbiology functions.
- Microsoft Word, Excel, PowerPoint.
Personal Information
- Passport Number: T2351022
- Father's Name: Mr. Ishwarbhai C Agree
- Date of Birth: 07/27/83
- Gender: Female
- Nationality: Indian
- Marital Status: Unmarried
Timeline
Senior Manager Microbiology (Q.C)
USV Laboratories PVT LTD
09.2019 - Current
Deputy Manager Microbiology (Q.C)
Alkem Laboratories PVT Ltd
06.2008 - 09.2019
Officer - Q.C.
Injectcare Parenteral Pvt. LTD
04.2007 - 06.2008
OFFICER Q.C.
Umedica Laboratories LTD
08.2005 - 04.2007
MBA(TQM) -
IIBPS
M.Sc - Microbiology
Veer Narmad South Gujarat University
B.Sc - Microbiology
Veer Narmad South Gujarat University
12th -
GSEB
10th -
GSEB
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