Jeyapandi Subramanian
Pharma Quality Leader
Indore
Summary
Dynamic and results-driven professional with over 22 years of extensive experience in Quality Operations within the pharmaceutical and biopharmaceutical industries. Expertise includes microbiology, sterility assurance, regulatory compliance, and quality management systems, with a proven track record in managing audits, investigations, and remedial projects to ensure adherence to stringent regulatory standards. Strong advocate for fostering creativity and innovation in the workplace, committed to driving organizational goals while enhancing product quality and patient safety. Passionate about leveraging knowledge and experience in green and brownfield projects to contribute effectively to team success and operational excellence.
Overview
22
22
years of professional experience
4
4
Languages
Work History
Director - Quality
Par Health [Par Formulations Ltd]
01.2024 - Current
- Leading the microbiology function as Director since January 2024.
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Implemented innovative solutions to solve complex problems, resulting in increased productivity and streamlined operations.
- Established a culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
- Facilitated cross-functional collaboration for improved decision-making processes within the organization.
- Successfully handled the first Injectable USFDA inspection at the site in March 2024.
- Actively involved in new product introductions at the plant, ensuring compliance, and smooth integration.
- Oversaw equipment qualifications in parallel with product launches to maintain regulatory standards.
- Driving microbiology strategy for sterile manufacturing, ensuring robust contamination control, and compliance.
Senior Manager Quality
Syngene International Ltd
06.2020 - 01.2024
- Led the Microbiology department to establish a compliant laboratory for a greenfield project.
- I represented Microbiology during EMA and USFDA inspections at the Bangalore unit (FY 2022–23) for biological manufacturing processes.
- Successfully completed the USFDA inspection at the Mangalore site in May 2023, with ZERO observations, reporting to the Head of Site Quality.
- Collaborated with vendors and project teams to make the microbiology lab fully operational.
- Spearheaded digitalization initiatives, including LIMS, ELN, TrackWise, LMS, and EDMS rollout across the site.
- Guided teams to achieve Right First Time (RFT) in QMS documentation, investigations, and critical change management.
- Worked closely with cross-functional teams to ensure quality and safety compliance in lab and site projects.
- Actively contributed to site-wide management initiatives such as Gemba Academy, Duty Manager group, and SME roles for project-specific needs.
- Participated in financial and operational projects, including asset verification, Project Endure (business continuity plan), and SQDECC visual management within Quality.
- Collaborated closely with peers from other departments to drive organizational success jointly as one cohesive unit.
Supervisor – QA [Microbiology]
Baxter India Private Limited
05.2019 - 06.2020
- Led the audit and remedial compliance for microbiological assurance; reported to the QA Microbiology Head.
- Managed a team of 23, ensuring regulatory compliance, and inspection readiness.
- Executed quality investigations, change management, and compliance assessments for previous observations.
- Reviewed and approved critical investigations, area/process qualifications, and equipment protocols.
- Collaborated with cross-functional teams to resolve critical issues, and maintain business continuity.
- Monitored CAPA effectiveness, and ensured continuous audit readiness for regulatory inspections.
- Collaborated with other departments to achieve organizational goals, fostering teamwork across various functions.
Manager – Quality Assurance
Pfizer Healthcare India Pvt Limited
09.2017 - 04.2019
- I worked in the QA Compliance team, driving inspection readiness (IR) initiatives in alignment with Global IR plans.
- Coordinated independent GMP assessments by third-party consultants (Lachman LLC, PwC, PAREXEL, Sidley LLC, Quintiles) post-US FDA inspection.
- Served as Back Room Manager during USFDA inspection and supported response preparation.
- Led remediation activities post-inspection, including review of aseptic interventions, fill weight challenges, QC testing, engineering calibration, and QA documentation.
- Managed critical investigations, technical write-ups, and RCA reviews with Global SMEs across aseptic processing, sterilization, and lyophilization.
- Supported site closure operations, including microbial stability testing on marketed products and equipment qualifications (isolators).
- Coordinated protocol execution for retesting marketed products with PAREXEL; received Recognition Award (Q4 2018) for contribution.
- Handled CAPA effectiveness monitoring, DI assessments, and ensured continuous audit readiness.
Manager – Quality Department
Dr Reddy’s Laboratories FTO-7
02.2016 - 09.2017
- Worked as Head Microbiology in FTO-7 on operational and compliance front during remedial phase as SME in Microbiology. Guided SAT [Sterility assurance team] at FTO7, Active participant in SIT - Site investigations team. Reported to Site Head – Microbiology [Duvvada] and team size was 35. Faced many regulatory inspections in this tenure.
- Faced USFDA inspection [Feb/Mar-2017] at FTO-7 Unit of Dr Reddy’s Labs and handled the queries during inspection technically [Inspectors – Mr. Justin Boyd and Mr. Toiyn]. Played a vital role in preparing the responses w r t Microbiology observations. Received appreciations from the top management for the way the queries handled during inspection.
Manager - Microbiology
Global Calcium (P) Ltd
04.2014 - 02.2016
- Worked as Head Microbiology and Manufacturing QA to handle quality operations. Worked with CFT’s to meet organizational goals. Successfully completed three regulatory inspections [USFDA, COFEPRIS, EUGMP & EDQM] Reported to Quality head and team size handled 12.
- Handled Microbiology laboratory without any Major or Critical observations during my tenure at GCPL, DRL and Syngene.
- Played a key role in COFEPRIS inspection - September 2015 and cleared with an appreciation as ‘Facility/Documentation are in-line with GMP requirements.’
- Played a vital role in the USFDA inspection - April 2015 and cleared with Zero observation in Microbiology. Worked to complete the requirements of joint inspection by EUGMP and EDQM in May 2014 and succeeded.
- At GCPL, played a vital role in the refurbishment of purified water systems in the facility and related qualifications to meet required pharmaceutical water quality in sterile API manufacturing unit.
- Key player in knowledge sharing / brain storming sessions / data analysis to evaluate appropriate CAPA especially in terms of improvisation of water systems / cleaning efficiency / gowning practices to reduce failures.
- Self-interested in training of lab personnel / production personnel for technical updates and trained around 500 employees in a year at GCPL through scheduled cGMP training. Trained microbiologists on key learnings from the investigation outcomes at Pfizer, Chennai.
Assistant Manager – Quality Department
Biocon Limited
04.2007 - 04.2014
- Worked as Central Audit and Compliance team member in QCM to handle QMS elements, Regulatory Affairs support, Validations, Equipment / area qualifications. Reported to site Microbiology Lead on Non-compliances. Involved directly in multiple regulatory inspections.
- Active team member in the SAT [Sterility Assurance Team] / SIT [Site Investigation Team] at Dr Reddy’s Laboratories to assure microbiological compliance at site.
- Played a vital role in audit preparation and Corporate Microbiological validations team across the sites of Biocon Ltd. Worked for harmonization of procedures / practices across the laboratories in different sites. Review of quality documents/records review in the formulation unit / Sterile and non-sterile API manufacturing facility.
- Extended support to other sites in the network for inspection preparations in Biocon [Site 3 – 2012] and received appreciations.
- Handled of miscellaneous microbiological validations – Hold time study for sterilized media and articles, prepared Cell suspensions / Disinfectant validations / Analytical method validations for suitability.
- Deployed the mechanism of RCA [Root cause analysis] for any failure and implement problem solving approach using analytical tools to eliminate recurrence and ensure smooth process validation.
- Handling of external vendors for clean room validations / equipment requalification. Handling of queries from regulatory agencies to prepare / file – DMF.
Research Assistant – Biotech Wing
Embio Research Centre
05.2005 - 03.2007
- Independently handled research activities in Biotech department for development / improvement of fermentation process. Trouble shooting in the manufacturing unit in terms of microbiological challenges.
- Microbiological Culture screening, selection, isolation and scale up of best isolates by substrate tolerance, by product and end-product inhibition.
- Culture media and process parameter optimization to increase productivity / batch yield in fermentation process. Was a Member in IBSC [Institutional Bio-Safety Committee] while working for ERC – Mahad.
- Handled tech transfer from lab scale to pilot level and writing PDR to meet cGMP requirements.
- Analytical method development, validation and transfer the same to the in-process labs as a key check in the existing fermentation process. Also, involved in whole cell and cell free bio-transformations [GMO’s] fermentation process developments.
- Literature survey – For new technologies, processes, and new drug developments routes [Biotech /Synthetic routes]. Good at the experimental data analysis and interpretation as and when required.
Officer – Micro lab
Gujarat Themis Biosyn Ltd
11.2003 - 05.2005
- Handled of inoculum development / Quality Control activities in fermentation process, Execution of R&D trials on process optimization and development.
Education
PG Diploma - Industry Program in Pharma Regulatory Affairs
Bioinformatics Institute of India
01.2010
M.Sc - Microbiology
M S University
Tirunelveli01.2003
B.Sc Zoology - Industrial Microbiology
M S University
Tirunelveli01.2001
Skills
Project / Operations management
Stakeholder engagement
Strategic planning
Problem-solving abilities
Effective communication
Timeline
Director - Quality
Par Health [Par Formulations Ltd]
01.2024 - Current
Senior Manager Quality
Syngene International Ltd
06.2020 - 01.2024
Supervisor – QA [Microbiology]
Baxter India Private Limited
05.2019 - 06.2020
Manager – Quality Assurance
Pfizer Healthcare India Pvt Limited
09.2017 - 04.2019
Manager – Quality Department
Dr Reddy’s Laboratories FTO-7
02.2016 - 09.2017
Manager - Microbiology
Global Calcium (P) Ltd
04.2014 - 02.2016
Assistant Manager – Quality Department
Biocon Limited
04.2007 - 04.2014
Research Assistant – Biotech Wing
Embio Research Centre
05.2005 - 03.2007
Officer – Micro lab
Gujarat Themis Biosyn Ltd
11.2003 - 05.2005
M.Sc - Microbiology
M S University
B.Sc Zoology - Industrial Microbiology
M S University
PG Diploma - Industry Program in Pharma Regulatory Affairs
Bioinformatics Institute of India