Akshay Phadnis
Pune
Summary
I am a knowledgeable Executive Officer, with approximately 8 years of experience in the microbiology department, adept at operating in diverse capacities to achieve business goals. Proficient in a wide range of areas, including testing, handling QMS, and Validation, Qualifications. Hardworking and proactive personnel with a disciplined execution.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Executive Officer
M.J. Biopharm Pvt. Ltd
Pune
05.2022 - Current
- The Biopharmaceutical unit is mainly involved in the production of recombinant human insulin and its derivatives API and formulation.
- Actively participated in Cell bank preparation and characterization.
- Actively participated in the installation of incubators, heating block, weighing balance, colony counter, and pipette.
- Have participated in BET method validation.
- Actively participated in product and raw material testing validation for TVC and detection of specified microorganisms (MLT).
- Actively participated in the sterilizer installation, and qualification; along with the load pattern development and validation.
- Have actively participated in the qualification of the classified area (tests related to microbiology include location selection, monitoring and risk assessment for the same).
- Sterility testing of the raw materials and finished product.
- Review of the documents.
- SOP and STP preparation.
- Have basic knowledge of logging and investigation of laboratory incidents.
- Have basic knowledge of logging and investigation of deviation.
- Have basic knowledge of logging change control.
- Have actively assisted in the preparation of quality risk assessment.
Quality Control Analyst I
Teva Pharmaceutical India Pvt. Ltd
Goa
08.2019 - 05.2022
- A pharmaceutical organization mainly involved in the production of medicine categories in solid oral dosage form
- Involved in the media preparation; sterilization of media, and growth promotion test of media
- Involved in the analysis of the finished product for TVC and detection of the presence of specified microorganisms
- Actively participated in technology transfer for the method validation
- Review of the document
- Have actively assisted in the investigation of OOS results
- Sterilizer validation schedule.
Senior Executive in QC Microbiology
Zydus Cadila Pvt. Ltd
Goa
09.2017 - 08.2019
- Pharmaceutical organization mainly involved in the production of sterile SVP and LVP, solid oral dosage form
- Involved in the sterility testing of raw material, primary packing material, sterilized accessories, and finished product
- Involved in the analysis of the finished product for TVC and detection of the presence of specified microorganisms
- Environment monitoring of classified areas
- Actively participated in the area qualification (for selection of VPC location)
- Actively participated in the media fill to simulate and verify aseptic procedures and practices.
Trine Microbiologist
Fresenius Kabi India Pvt. Ltd
Pune
07.2016 - 09.2017
- Pharmaceutical organizations mainly involved in the production of sterile SVP and LVP
- Environment monitoring of classified areas
- Trending of environment monitoring data
- Cleaning of sterility classified area
- NVPC monitoring
- Water sampling
- BET of water and finished product
- Sterility observation and assist in the testing
Education
Master of Science - Microbiology
Savitribai Phule Pune University
Pune06-2016
Bachelor of Science - Microbiology
Tuljaram Chaturchand College Baramati
Baramati Pune04-2014
12th (Higher Secondary Examination) -
Maharashtra State Board
05-2011
10th (Senior Secondary Examination) -
Maharashtra State Board
04-2009
Skills
- EDMS handling
- Handling of the events, change control, and laboratory incidents
- Microbial Limit Test testing and method validation
- Sterility testing
- Bacterial Endotoxin testing, and method validation
- Cell bank analysis
- Incubator Qualification
- Classified area qualification
- Have basic knowledge of CSV
- Autoclave Validation and load pattern development
- Basic knowledge of Risk assessments
Certification
- Having Competent Technical Staff Approval for Microbiology Testing (TST) from the Food & Drugs Administration (Maharashtra State).
Timeline
Executive Officer
M.J. Biopharm Pvt. Ltd
05.2022 - Current
Quality Control Analyst I
Teva Pharmaceutical India Pvt. Ltd
08.2019 - 05.2022
Senior Executive in QC Microbiology
Zydus Cadila Pvt. Ltd
09.2017 - 08.2019
Trine Microbiologist
Fresenius Kabi India Pvt. Ltd
07.2016 - 09.2017
Master of Science - Microbiology
Savitribai Phule Pune University
Bachelor of Science - Microbiology
Tuljaram Chaturchand College Baramati
12th (Higher Secondary Examination) -
Maharashtra State Board
10th (Senior Secondary Examination) -
Maharashtra State Board
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