Pankaj Swain
Bharuch
Summary
Insightful Manager with experience directing and improving operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, market trends and regulatory requirements of industry operations. Talented leader with analytical approach to business planning and day-to-day problem-solving.
Overview
16
16
years of professional experience
Work History
Manager QC Microbiology
Milan Laboratories Pvt. Ltd
01.2023 - Current
- Reading of all GMP data of laboratory in compliance for laboratory readiness for audits
- Management of microbiology lab in terms of requisites, deliverables and qualification status
- Participate in inspections conducted by regulatory agencies like USFDA, Health Canada and got appreciated by inspectors, got passed providing compliance within deadline
- Ensure timely planning, successful media fill validation, equipment qualification, product AMV & Inhouse validation studies
- Handling of QMS documents- Change control, CAPA, Incidence, Deviations & Investigation
- Provide support for all Media fill, Sterility failure investigations, EM excursions at site, with identification of root cause and effective CAPA
- Performs special projects and other duties as assigned
Manager Microbiology
Swiss Parenteral
05.2021 - 12.2022
- Supervision and training and development of QC microbiology staff and provide guidance on best aseptic practices
- Communication with manufacturing facilities, and external department staff on microbiological and environmental operational issues
- Serve as reviewer of facility, equipment and product test data and reports
- Successfully faced and headed the department during MHRA, USFDA Inspection and customer audits like Cipla, Abott
Assistant Manager
Emcure Pharmaceuticals
12.2020 - 05.2021
- General administration and planning of activities of Microbiology department
- Preparation implementation and maintenance of SOP, Protocols and reports in Microbiology department
Assistant Manager
Lincoln Pharmaceuticals Limited
08.2019 - 11.2020
- Review of BET test by Gel-clot method, validation and calibration of Autoclave, LAF, DPB
- Implementation and sustaining concept of right first time
- Reduction in OOS & OOT, improvement in sample per analyst; driving improvement projects including bottlenecks identification and resolution, procedure vs practice gaps, simplification of SOPs and alike
- Provide support for all EM excursions at site, with identification of root cause and effective CAPA
- Successfully faced and passed EU-GMP audit with giving compliance reports within deadline
Senior Executive cum Reviewer
Ajanta Pharma Limited
07.2017 - 07.2019
- Reviewing of all Sterility test results, Media preparation records, Autoclave qualification, Water tests, BET & daily records
- Responsible for SOP, Protocol preparation & revision and execution
- Training all staff members on cGMP, ALCOA, BET, Media fill
- Participated in audits by ROW countries
Executive
Micro Labs Pvt Ltd.
02.2015 - 06.2017
- General administration and planning of activities of Microbiology department
- Preparation implementation and maintenance of SOP, Protocols and reports in Microbiology department
- Faced internal CQA audits, WHO, IDMA, ISO
- Handled the greenfield project to set up of new laboratory, hand-on experience of conducting review of Media Fill (DPI & Eye Drops)
Management Staff Member
Cipla Pvt.Ltd
05.2009 - 01.2015
- Performed Environment monitoring in Aseptic sterile facility, Sampling and Water analysis of WFI, Purified water, PSG samples, Double door Autoclave operation, handled microbial cultures, carried out antimicrobial effectiveness test for oral liquids, ointments, Sterility tests of Dry powder injection vials
Education
MSc - Microbiology
Chatrapati Sahuji Maharaj University
KanpurBSc - Microbiology
Chatrapati Sahuji Maharaj University
Kanpur12th -
Deepika E.M School
Rourkela10th -
Deepika E.M School
RourkelaSkills
- Proficiency in QMS activities, like OOS, OOT, change control, and deviations
- Microbiological validation studies
- Successfully faced regulatory inspections of EU-GMP, MHRA, and USFDA
- Operations management
- Workforce management
- CCS, as per EU Annex 1
- Execution of risk assessment by FMEA tools
- Problem resolution
- Leadership/communication skills
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
Personal Information
Home Contact
9776066502
Disclaimer
I hereby declare that the information mentioned above is true to the best of my knowledge
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
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