Amit Mahadev Jagadale
Chakan
Summary
Accomplished quality assurance leader with expertise in regulatory compliance and microbiology testing. At Biocon Biologics, spearheaded the establishment of a new microbiology lab, enhancing operational efficiency. Recognized for analytical problem-solving and cross-functional collaboration. Proficient in quality management systems and audit compliance.
Overview
19
19
years of professional experience
Work History
Deputy Manager Quality Assurance (Analytical QA)
Biocon Biologics Limited
Bangaluru
09.2020 - Current
- Quality Assurance and Site Microbiology Compliance.
- Oversee laboratory activities related to microbiology department, Molecular biology and Analytical Section.
- Responded to regulatory queries and audit observations.
- Keep microbiology Laboratory in regulatory compliance mode.
- Strengthened microbiology department through supportive leadership and resource allocation.
- Batch release/ Review of Microbiology test data, COA review and Approval.
- Managed QMS activities for microbiology department, including change control, deviation, risk assessment, impact assessment, out of specification, microbial excursions, and investigations. Reviewed and approved documentation, providing technical support for timely closure of QMS elements.
- Actively Participate in investigation related with QMS elements, Review and Approval of Investigations, final closure of QMS elements (In Track wise).
- Review of Microbial Test Method Validation Protocol and report (Sterility, BET, MLT and Contamination Check).
- Timely Closure of QMS and Verification of Change Control and CAPA implementation and closure of Same within proposed timeline.
- Review of in process and Finish product microbial analysis data for Batch release.
- Execution, Review and Approval of Periodic re-qualification and Performance qualification activities. Of Equipment/Instrument and Clean room area.
- Periodic review of Environment monitoring and Water System Monitoring programme.
- Review of Testing records, Logbooks, Calibration record, Validation record, sub culturing record and other Microbiology department related records as per the requirement.
- Review of TTD (Technical Transfer Documents) and JOS (Justification of Specification) related with New Products.
- Review and approval of Microbiology department related SOPs, Study Protocols, Reports and Specification.
- Review and approval of Validation and Re-qualification Protocol (e.g. For Water Analysis (Microbiological and chemical), Microbial Limit Test, Bioburden, sterility testing, Disinfectant Efficacy testing).
- Review of Calibration and Validation reports of Instruments/ equipment’s.
- Reviewing and Approving of microbiological reports and records.
- Reviewing IQ/OQ/PQ documents of equipment and instrument related to Microbiology and production Department.
- Provide technical support for production and microbiology department for investigation of deviation, incidents related with microbiology.
- Review and Approval of Environment monitoring and water trends and summary (Monthly Quarterly and annually).
- Review and Approval of Isolate Summary of Water and Environment Monitoring.
- Review and Approval of Product testing and Inprocess Sampling testing Trends.
- Prepared, reviewed, and approved trend analysis reports for QMS elements, including deviations, OOAC, OOAL, OOT, OOS, laboratory incidents, data integrity, and human error.
- Audit trail review related with Quality Control and Microbiology related.
- Review of report of Cell based Bioassay report and participate in investigations related with QMS elements.
- Preparation and revision of Quality Assurance SOPs.
- Maintenance of Cell Bank System (Characterization, Stability and consumption).
- Implementation and Maintenance of GLP in Microbiology Laboratory.
- Engaged in regulatory audits to uphold quality assurance protocols.
- Globalization/ Harmonization of Quality Assurance System and Procedures.
- Execution of Product Quality and Patent Safety Assessment of Batches having Bioburden Excursions (Inprocess/ Final DS).
- Provide Support to Regulatory for Dossier Submission for providing data and review of Dossier.
- Biocon Biologics limited is manufacturing Biosimilar product including Insulin and Monoclonal Antibodies.
- Provide Compliance and technical support for HVAC and water generation and distribution system (Purified water, Water for Injection) Qualification after Expansion of Manufacturing Facility in Biocon Biologics.
- Established QA Strategies in newly established plant B5.
- EM LIMS implementation in Microbiology Laboratory.
- Establishment of New Microbiology Lab in Block 5 Facility.
- Qualified Auditor for Self inspection, Auditing the Manufacturing, Production, Packaging and Engineering department as per schedule and resolved Gaps.
- Microbial testing method development for new products.
- Suitability testing of Antimicrobial effectiveness testing.
- Disinfectant Qualification and Inhouse microbial isolate Management.
- Development and Qualification and Validation of Inhouse methods (Upstream and Downstream Samples).
- Facing USFDA, EMA and other regulatory Audits and provide compliance to respective observation related with Microbiology Function as a part of Audit Compliance Team.
- Performed assessments to ensure adherence to updated regulatory standards.
- Handling product related OOS and OOT investigation, Laboratory and Manufacturing.
- Product Quality and Patient Safety impact Assessment of Inprocess Bioburden Excursions.
- Supported execution of cost-saving initiatives and elimination of redundant activities through quality risk assessment.
- Honored with the Achiever Award in 2022 for contributions to the qualification and initiation of a new facility within set timelines.
- Honored with the Achiever Award in 2023 for successfully releasing batches within the internal turnaround time.
- Support for Yellow belt, Green belt and black belt projects of QC- Analytical, QC-Microbiology and Manufacturing.
- Involved in Manufacturing investigation (OOL, OOS and OOT).
Assistant Manager Quality Control – Microbiology
Wockhardt Limited
Waluj
05.2018 - 09.2020
- Led microbiology section and oversaw all testing activities in microbiology department.
- Provided analytical support to production department (API and sterile formulation facility) to ensure timely execution of production activities.
- Oversaw production of biological API and sterile injectable products.
Assistant Manager Quality Control – Microbiology
Indoco Remedies Limited
Verna
03.2017 - 04.2018
- Ensured compliance with USFDA standards for sterile ophthalmic and small volume injectable production, maintaining product safety and quality.
- Managed activities in microbiology department to ensure smooth operations.
- Assisted the production and research and development departments in conducting analytical evaluations.
Management Staff (Microbiology Section Head)
Cipla BioTec Private Limited
Goa
06.2015 - 03.2017
- Oversaw compliance with regulatory standards and quality assurance protocols.
- Managed departmental operations to ensure compliance with laboratory standards and optimize efficiency.
- Developed and implemented standard operating procedures for laboratory activities.
- Led cross-functional teams to enhance operational efficiency in biopharmaceutical processes.
Sr. Executive in Quality Control Department
Agio Pharmaceutical, Pvt, Ltd.
Pune
12.2014 - 06.2015
- Sterile Injectables, Tablet, Capsule and ointment Manufacturing
- Developed strategic initiatives that accelerated product development timelines and ensured compliance.
- Led cross-functional teams to streamline project delivery and improve operational efficiency.
- Managed stakeholder relationships to align project goals with overall organizational objectives.
Executive in Microbiology Department
Wockhardt Limited
Aurangabad
04.2014 - 12.2014
- Oversaw production of biological API and sterile injectables to ensure quality.
- Led cross-functional teams to enhance operational efficiency and streamline processes.
- Developed strategic initiatives to align business goals with market trends.
- Coordinated project timelines and resource allocation for critical business functions.
- Established Microbiology Lab to enhance research capabilities.
Senior Quality Control Officer
Flamingo Pharma Private Limited
Nanded
09.2012 - 03.2014
- Performed routine inspections of raw materials and finished products, ensuring adherence to quality standards.
- Implemented quality control procedures to ensure adherence to industry standards.
- Partnered with production teams to swiftly identify and resolve quality issues, enhancing overall product integrity.
- Managed tablet and capsule manufacturing processes to ensure product quality and compliance.
Microbiologist
Albany Molecular Research, Inc. (AMRI)
Aurangabad
01.2011 - 10.2012
- Conducted microbial testing and analysis, confirming product safety and quality.
- Developed and validated microbiological methods for quality control.
- Produced sterile and nonsterile APIs, ensuring compliance with industry standards.
- Collaborated with cross-functional teams, enhancing research project outcomes.
Officer
M/S TULIP LAB Private Limited
Shirur
03.2010 - 01.2011
- Managed daily operations, ensuring compliance with company policies and regulatory standards.
- Oversaw team schedules and coordinated interdepartmental workflow to optimize production.
- Implemented quality control measures, maintaining product standards and reducing defects.
- Produced various pharmaceutical forms to meet production requirements.
Microbiologist
M/s Twilight Litaka Pharma. LTD.
PUNE
06.2007 - 03.2010
- Conducted microbial testing to ensure product quality and safety.
- Developed and validated microbiological methods, streamlining processes for multiple projects.
- Analyzed samples with advanced laboratory equipment, enhancing accuracy of quality assessments.
- Produced pharmaceutical forms, ensuring compliance with safety and quality regulations to support product integrity.
Education
M.Sc. - Microbiology
Yashwantro Mohite College, Bharti Vidyapeeth University
Pune 03-2007
Skills
- Regulatory compliance
- Quality management
- Process quality assurance
- Audit management
- Cleanroom validation
- Root cause analysis
- Root cause investigation
- Data analytics
- Risk management
- Cross-functional collaboration
- Analytical problem solving
- Leadership and team management
Accomplishments
- Provide Compliance and technical support for HVAC and water generation and distribution system qualification after expansion of manufacturing facility in Biocon Biologics.
- Established QA Strategies in newly established plant B5.
- EM LIMS implementation in Microbiology Laboratory.
- Establishment of New Microbiology Lab in Block 5 Facility.
- Qualified Auditor for Self inspection, Auditing the Manufacturing, Production, Packaging and Engineering department as per schedule and resolved Gaps.
- Microbial testing method development for new products.
- Suitability testing of Antimicrobial effectiveness testing.
- Disinfectant Qualification and Inhouse microbial isolate Management.
- Development and Qualification and Validation of Inhouse methods.
- Facing USFDA, EMA and other regulatory Audits and provide compliance to respective observation related with Microbiology Function as a part of Audit Compliance Team.
- GAP assessment against revised regulatory Guidelines.
- Handling product related OOS and OOT investigation, Laboratory and Manufacturing.
- Product Quality and Patient Safety impact Assessment of Inprocess Bioburden Excursions.
- Support for execution of cost saving and redundant activity removal projects with Quality Risk Assessment.
- Awarded with Achiever Award in year 2022 for support to Qualification and start new facility within predefined timelines.
- Awarded with Achiever Award 2023 for releasing batches within internal TAT.
Audit Experience
- USFDA - United State Food and Drug Administration.
- ANVISA - Agencia Nacional de Vigilancia Sanitaria (Brazil).
- INVIMA - Columbia.
- Russian GMP.
- National Food and Drug Authority Uganda.
- The Turkish Medicines and Medical Agency (Turkey).
- MCC - Medicinal Control Council (South Africa).
- Danish Medicines Agency (Denmark).
- TGA - Therapeutic Goods Administration (Australia).
- National Agency of Food and Drugs Administration and Control (NAFDAC) (Nigeria).
- EMEA (Europe).
- MHRA - Medicines and Healthcare Product Regulatory Agencies (UK).
- IDA - International Drug Associations.
- WHO - World Health Organizations.
- Medicinal Control Authority of Zimbabwe.
- HMA - Heads of Medicines Agencies.
Personal Information
- Date of Birth: 06/15/85
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Disclaimer
I hereby declare that all the above detail given by me are true and correct to the best of my knowledge.
Current Job
Associate Manager Quality Assurance, Biocon Biologics Limited, Biotech Park, Electronic City, Phase-II, Bangaluru, Karnataka, 560100, 09/19/20, Quality Assurance and Site Microbiology Compliance., Oversee laboratory activities related to microbiology department, Molecular biology and Analytical Section., Provide response to regulatory Queries and Audit Observations., Keep microbiology Laboratory in regulatory compliance mode., Empowerment of Microbiology department., Batch release/ Review of Microbiology test data, COA review and Approval., Handling of QMS activities related to Microbiology department., Review of Microbial Test Method Validation Protocol and report., Timely Closure of QMS and Verification of Change Control and CAPA implementation., Daily shop floor round in microbiology department to maintain regulatory compliance., Periodic review of Environment monitoring and Water System Monitoring programme., Review of Testing records, Logbooks, Calibration record, Validation record, sub culturing record and other Microbiology department related records., Review and approval of Microbiology department related SOPs, Study Protocols, Reports and Specification., Review and approval of Validation and Re-qualification Protocol., Provide technical support for production and microbiology department for investigation of deviation, incidents related with microbiology.
Carrier Profile - Summary
Result oriented professional with 18 years experience in Microbiology and Quality Assurance function in Sterile, OSD, Sterile API, Biological Drug Substance and Drug Product Manufacturing. Expertise in Microbiology testing and Aseptic process operations with proven track record of driving quality improvement, ensuring regulatory compliance and leading cross functional teams.
Timeline
Deputy Manager Quality Assurance (Analytical QA)
Biocon Biologics Limited
09.2020 - Current
Assistant Manager Quality Control – Microbiology
Wockhardt Limited
05.2018 - 09.2020
Assistant Manager Quality Control – Microbiology
Indoco Remedies Limited
03.2017 - 04.2018
Management Staff (Microbiology Section Head)
Cipla BioTec Private Limited
06.2015 - 03.2017
Sr. Executive in Quality Control Department
Agio Pharmaceutical, Pvt, Ltd.
12.2014 - 06.2015
Executive in Microbiology Department
Wockhardt Limited
04.2014 - 12.2014
Senior Quality Control Officer
Flamingo Pharma Private Limited
09.2012 - 03.2014
Microbiologist
Albany Molecular Research, Inc. (AMRI)
01.2011 - 10.2012
Officer
M/S TULIP LAB Private Limited
03.2010 - 01.2011
Microbiologist
M/s Twilight Litaka Pharma. LTD.
06.2007 - 03.2010
M.Sc. - Microbiology
Yashwantro Mohite College, Bharti Vidyapeeth University