BABULAL PARMAR
Sr. Executive Production API
Bhopal
Summary
Multidisciplinary professional with 23+ years of experience in API production, technical services, EHS with ISRS. I leverage academic training in Science, Technology, to drive organizational growth and operational excellence, embracing innovation with dedication and integrity. Passionate about continuous learning, mentoring, and implementing sustainable improvements through effective Corrective and preventive action in day today operations.
Overview
24
24
years of professional experience
Work History
Sr. Executive API production
Lupin Ltd Mandideep
10.2011 - Current
- Lead process optimization and production of APIs and intermediates, driving scale up of new molecules from plant level validation to commercial manufacture. Coordinate experimental studies with R&D and apply process engineering principles to ensure robust, safe, and environmentally compliant operations. Participate in product HAZOPs and select appropriate hardware for reliable process execution. Supervise a team of ~40 personnel to run 24×7 plant operations.
- Contributed to the recycling of distilled water at the CLIS stage in Lupin.
- Worked on capacity enhancement of Lisinopril, yield optimization, and reduction of consumable usage in compliance with cGMP standards.
- Operations, ensuring GMP compliance, safety, and readiness for audits and inspections.
- Incident Investigation & RCA: Actively lead incident investigations and Root Cause Analyses (RCA), implement corrective and preventive actions, and troubleshoot process issues to improve operational reliability and drive continuous improvement.
- Project & Permit Support: Provide critical operational support to the Projects Department, including permit approvals during silent hours, to enable safe and uninterrupted execution of project activities.
- Cost Savings & Process Improvements: Lead and support cost-saving initiatives, process optimization projects, and pollution-prevention measures that enhance efficiency, reduce waste, and contribute to overall operational excellence.
- HAZOP & MOC Participation: Participate in HAZOP studies and Management of Change (MOC) reviews, delivering technical evaluations and value-adding recommendations for equipment selection and process modifications.
- Six sigma teqniques utilization for the variation analysis and to desian an experiments with DMAIC principal
- Coordinate production activities with QC, Stores, P&D, and Planning to ensure seamless operations.
- Supervise plant operations in collaboration with Safety, Housekeeping, and other departments to maintain GMP culture and enforce discipline.
- Meet production targets by optimizing resource utilization and reporting improvement opportunities to the Production Manager.
- Develop and maintain SOPs for operations, cleaning, and manufacturing in accordance with established procedures.
- Execute API and intermediate production strictly as per approved instructions and batch documentation.
- Review and finalize production records; report, investigate, and close process deviations promptly.
- Ensure calibration of instruments and equipment is performed, documented, and up to date.
- Support validation activities by preparing, reviewing, and approving validation protocols and reports.
- Qualify new or modified equipment and facilities before commissioning and routine use.
- Contribute to production planning and prepare operational reports for senior management
- To implement facility, equipment, and process modification activities in the plant.
- To ensure that all plant jobs are carried out as per set procedures.
- Deployment and mobilization of manpower for production planning.
- To depute plant personnel for training and development jobs.
- To carry out OOS (Out of Specification) and OOT (Out of Trend) investigation.
- To carry out self-audit and review & sign documents i.e., BPR, Records, work permits, risk assessment documents.
- To ensure that activities are carried out in compliance with EHS & GMP norms. Ensuring usage of PPE’s, compliance to work permit checks. Event reporting maintains process safety.
- To ensure activities are carried out in compliance with EHS & GMP norms. Ensuring usage of PPE’s, compliance to work permit checks. Event reporting maintains process safety.
- To undergo EHS training programs and participate in promotional campaigns and assist in emergency handling.
- To ensure that plant modification jobs are carried out as per the procedure mentioned in EHS guidelines. To conduct risk assessment studies, plant audits, and ensure compliance of recommendations, active involvement in event investigations, and ensure compliance of proposed CAPA’s and process safety on shop floor.
- Do you want to relate these responsibilities to your experience or analyze them for a specific job role
Executive API Production
Torrent Pharma Ltd.
11.2009 - 10.2010
- Gained foundational knowledge of all operations in a multiproduct facility and contributed to the setup of a newly constructed plant commissioned for product Topiramate production. Applied skills in equipment qualification, supported facility design, and established Critical Process Parameters (CPP) and Critical Safety Parameters (CSP) to ensure safe and efficient operations.
- Prior to Work
Sr. Officer Production
Tonira Pharma Ltd.
10.2008 - 11.2009
- Played a key role as GMP Coordinator during the Japan Regulatory Audit (PMDA) at Tonira Ankleshwar in November 2008, ensuring compliance with international standards and successfully supporting audit readiness.
- At Tonira Pharma, expanded my experience and strengthened skills by contributing to documentation procedures in line with pharmaceutical regulatory standards and cGMP guidelines. Assessed existing systems to identify gaps and improvement opportunities, and supported change management initiatives accordingly. Key contributions included:
- Preparation of Batch Manufacturing Records (BMR)
- Development and review of validation documents (protocols & reports: OQ, PQ, Cleaning Validation, Process Validation)
- Execution of Change Control processes
- Handling of Deviation reports
- Drafting and updating Standard Operating Procedures (SOPs)
Officer Production
Zydus Cadila Healthcare Ltd.
12.2006 - 10.2008
- Collaborated on the SLIM (McKinsey & Company) project at Zydus Cadila, contributing to enhanced production capacity of Paroxetine hydrochloride hemihydrate.
Production
IPCA Laboratories Ltd.
12.2001 - 11.2006
- Successfully recovered the third crop from the mother liquor of Artesunate (Hexane ML), earning an Appreciation Certificate from the President of Ipca Laboratories Ltd., Ratlam.
- Honored with Total Quality Management (TQM) Awards at Ipca Laboratories for driving system improvements through small group activities.
- Coordinate with QC, Stores, P&D, and Planning departments to streamline production-related activities.
- Supervise and control plant operations in collaboration with relevant departments, ensuring safety, housekeeping, GMP compliance, and discipline.
- Achieve production targets through optimal resource utilization and report performance improvements to the Production Manager.
- Develop and implement SOPs for operations, cleaning, and manufacturing in line with established procedures.
- Execute API and intermediate production processes as per pre-approved instructions.
- Review, complete, and maintain production records; report and investigate any process deviations.
- Ensure timely calibration of equipment and proper documentation of results.
- Contribute to preparation, review, and approval of validation activities.
- Verify qualification of new or modified equipment and facilities prior to use.
- Participate in production planning and prepare detailed reports for senior management.
Education
M.Tech - WILP program
BITS Pilani
01-2020
M.B.A - undefined
Sikkim Manipal University
01-2018
M.Sc - Chemistry
Bhoj Open University
Bhopal01-2009
B.Sc - Chemistry
Vikram University
Ujjain01-2000
Higher Secondary - undefined
M.P. Board
Bhopal01-1997
High School - undefined
M.P. Board
Bhopal01-1995
Skills
Handling of SAP, DMS, QAMS
Hand on experience Six Sigma (Green Belt)
Knowledge and on hand experience of TPM and TQM
LMS (Learning management system) SABA software
Automation SCADA, HMI
Emergency preparedness ISRS and EHS
E-log and QAMS
Accomplishments
- Successfully Faced the USFDA and regulatory audits
- Awarded for TQM and kaizen.
- Successfully completed the project at Lupin, Zydus Cadila, IPCA laboratories
- Appreciation letter for number of suggestion logging.
- SLIM project at Zydus Cadila: production capacity enhancement by line balancing and small changes.
- Reduction in process time cycle.
- Inventory reduction and system modifications through team brainstorming.
Timeline
Sr. Executive API production
Lupin Ltd Mandideep
10.2011 - Current
Executive API Production
Torrent Pharma Ltd.
11.2009 - 10.2010
Sr. Officer Production
Tonira Pharma Ltd.
10.2008 - 11.2009
Officer Production
Zydus Cadila Healthcare Ltd.
12.2006 - 10.2008
Production
IPCA Laboratories Ltd.
12.2001 - 11.2006
M.B.A - undefined
Sikkim Manipal University
M.Sc - Chemistry
Bhoj Open University
B.Sc - Chemistry
Vikram University
Higher Secondary - undefined
M.P. Board
High School - undefined
M.P. Board
M.Tech - WILP program
BITS Pilani
Declaration
I hereby declare that the information provided above is true to the best of my knowledge and belief. Date: _____________ Signature: (BABULAL PARMAR)
Technical & Professional Qualifications
Post Graduate Diploma in Computer Application (PGDCA), MCRPVV, Bhopal