Pankaj Swain
Bharuch
Summary
Results-driven Manager known for high productivity and efficient task completion. Specialize in strategic planning, team leadership, and operational improvement. Excel in communication, problem-solving, and adaptability, ensuring seamless project execution and team cohesion. Accomplished professional specializing in microbiological validation studies and QMS activities. Known for effective CAPA execution and successful regulatory inspections, ready to enhance quality standards and operational outcomes.
Overview
17
17
years of professional experience
Work History
Manager QC Microbiology
Milan Laboratories Pvt. Ltd
01.2023 - Current
- Ensure timely planning, successful media fill validation, equipment qualification, product AMV & Inhouse validation studies
- Managed microbiology lab requisites and deliverables, ensuring operational readiness and compliance through effective qualification oversight.
- Contributed to inspections by regulatory agencies such as USFDA, EU-GMP, and Health Canada.
- Monitored staff performance and addressed issues through regular evaluations, promoting accountability and professional development.
- Managed QMS documents, including change control, CAPA, incidents, deviations, and investigations.
- Supported media fill and sterility failure investigations, identifying root causes and implementing CAPA to enhance compliance and operational integrity.
- Managed out-of-specification, out-of-trend, and microbiological deviation investigations to ensure compliance.
- Revised and implemented various documents, including SOPs, STPs, and protocols.
Manager Microbiology
Swiss Parenteral
05.2021 - 12.2022
- Supervised and trained QC microbiology staff, enhancing compliance and operational standards through guidance on best aseptic practices.
- Collaborated with manufacturing facilities and external department staff on microbiological and environmental operational issues, ensuring alignment and swift resolution of concerns.
- Reviewed facility, equipment, and product test data and reports for accuracy and regulatory compliance.
- Ensure compliance during internal, external audits like Russia-EAEU, MHRA and customer audits like Cipla, Abbott.
Assistant Manager
Emcure Pharmaceuticals
12.2020 - 05.2021
- Developed, implemented, and maintained SOPs, protocols, and reports for Microbiology department, ensuring adherence to quality standards
- Administered and planned activities of Microbiology department, enhancing operational efficiency
- Provide microbiological support in plant validation and qualification activities
- Prepared monthly trend and summary reports of water systems and EM, facilitating compliance and informed decision-making
Assistant Manager
Lincoln Pharmaceuticals Limited
08.2019 - 11.2020
- Implemented and sustained right-first-time processes, improving operational efficiency and reducing error rates.
- Reduced OOS and OOT incidents while improving samples per analyst; led improvement projects to identify and resolve bottlenecks, address procedure vs practice gaps, and simplify SOPs.
- Supported EM excursions on site by identifying root causes and implementing effective corrective actions, minimizing recurrence of issues.
- Passed EU-GMP audit by delivering compliance reports within deadlines.
- Reviewed BET tests using Gel-clot method to ensure compliance with standards.
Senior Executive cum Reviewer
Ajanta Pharma Limited
07.2017 - 07.2019
- Reviewed sterility test results, media preparation records, autoclave qualifications, water tests, BET, and daily records, ensuring adherence to regulatory standards and enhancing product safety.
- Prepared and revised SOPs and protocols, improving operational consistency and reinforcing regulatory compliance across processes.
- Trained staff on cGMP, ALCOA, BET, and media fill procedures, fostering a culture of quality and compliance within the team.
- Assisted in audits for ROW countries to ensure compliance with international quality standards.
Executive
Micro Labs Pvt Ltd.
02.2015 - 06.2017
- Led greenfield project for new laboratory setup, reviewing Media Fill (DPI & Eye Drops) for compliance with regulatory standards
- Developed and maintained SOPs, protocols, and reports for Microbiology department to ensure adherence to quality standards
- Coordinated activities for Microbiology department to support seamless operations
- Conducted internal CQA audits and participated in external inspections by WHO, IDMA, and ISO.
Management Staff Member
Cipla Pvt.Ltd
05.2009 - 01.2015
- Microbial analysis of sterile and non-sterile raw materials, in-process samples, finished products, PM and stability.
- Performed culture dilution and maintenance of microbial samples in laboratory settings.
- Prepared and maintained records of media preparation and sterilization procedures, enhancing laboratory documentation accuracy.
- Monitored aseptic sterile facility environment, sampled and analyzed water for WFI, purified water, and PSG to ensure compliance with safety standards.
- To test the BET samples of water for injection & products by Gel-clot method.
- Detected and identified microorganisms through gram staining and biochemical testing to support quality assurance efforts.
Education
MSc - Microbiology
Chatrapati Sahuji Maharaj University
KanpurBSc - Microbiology
Chatrapati Sahuji Maharaj University
Kanpur12th -
Deepika E.M School
Rourkela10th -
Deepika E.M School
RourkelaSkills
- Microbiological validation studies
- Media fill validation
- Regulatory inspections
- Proficiency in QMS activities, like OOS, OOT, change control, and deviations
- CCS, as per EU Annex 1
- Execution of risk assessment by FMEA tools
Home Contact
9776066502
Disclaimer
I hereby declare that the information mentioned above is true to the best of my knowledge
Personal Information
- Expected CTC: As per policy
- Notice Period: 3 months
- Gender: Male
- Nationality: Indian
- Marital Status: Married
- Religion: Hindu
- Title: Quality Control Microbiology
Projects
IBI BIOSOLUTIONS, Insilico Drug designing for HIV/AIDS, 30 Days, Drug Designing for Human Immunodeficiency Virus using Reverse Transcriptase Enzyme and various Bioinformatics softwares., Chandigarh, Punjab Capital Hospital, Study and diagnosis of Malaria, 30 Days, QBS and ICT test for blood detection., Bhubaneswar, Odisha BILT, Application of Biotechnology, 30 Days, Enzyme technology in Paper Industry for generation and treatment of water., Jeypore, Odisha
Timeline
Manager QC Microbiology
Milan Laboratories Pvt. Ltd
01.2023 - Current
Manager Microbiology
Swiss Parenteral
05.2021 - 12.2022
Assistant Manager
Emcure Pharmaceuticals
12.2020 - 05.2021
Assistant Manager
Lincoln Pharmaceuticals Limited
08.2019 - 11.2020
Senior Executive cum Reviewer
Ajanta Pharma Limited
07.2017 - 07.2019
Executive
Micro Labs Pvt Ltd.
02.2015 - 06.2017
Management Staff Member
Cipla Pvt.Ltd
05.2009 - 01.2015
MSc - Microbiology
Chatrapati Sahuji Maharaj University
BSc - Microbiology
Chatrapati Sahuji Maharaj University
12th -
Deepika E.M School
10th -
Deepika E.M School