Kalpesh Nikam
Jalgaon
Summary
Detail-oriented Pharmaceutical Quality Control Professional with 15 years of experience in quality operations and regulatory compliance. Led QC activities to ensure timely release of materials while adhering to cGMP standards. Managed investigations, implemented CAPA, and maintained quality documentation. Guided cross-functional teams and conducted training to improve laboratory performance and regulatory preparedness.
Overview
15
15
years of professional experience
Work History
Manager
PIRAMAL PHARMACEUTICALS LIMITED
Kurla
09.2025 - Current
- Working in the Corporate Quality Assurance (CQA) Department, providing support for quality functions at Piramal Pharma Limited overseas facility in Riverview, Michigan, USA.
- Review of analytical data generated in the analytical lab (QC/AS) including but not limited to cleaning verification/validation data, raw materials, intermediates, finished products, stability, and method validation data according to cGMP, GDP, in a timely manner and activity signoff as per site procedures.
- Conducted data reviews virtually or on-site across the Piramal plants.
- Coordinated review activities with site team, sharing identified deficiencies for corrective actions.
- Review of Specification, Test procedure, analytical Method validation Protocol and Report, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc as per site procedure.
- Create and revise working test methods in compliance with compendia requirements and laboratory practices to support analytical testing.
- Conducted trend analysis of release testing data, identifying out-of-trend (OOT) results to support quality assurance.
- To review QMS documents such as Change control, CAPA, Deviation, OOS, OOT etc.
- Reviewed analytical data from external laboratories, ensuring compliance with specifications and quality standards.
- Develop, revise, and review stability protocols and documentation in accordance with ICH guidelines and product-specific requirements, prepare stability summary reports with statistical analysis and trending to evaluate data and ensure regulatory compliance and data integrity.
Assistant Manager
GLENMARK PHARMACEUTICALS LIMITED
Indore
02.2023 - 09.2025
- Led and coordinated investigations into lab incidents, OOS, OOT, and deviations to identify root causes and facilitate corrective actions.
- Reviewed and approved investigation reports for OOS, OOT, lab incidents, and deviations, ensuring compliance with quality standards.
- Conducting investigations for out of specification, out of trend, laboratory incident and deviations.
- Responsible for performing Quality Risk Management and taking action to reduce the error.
- Proposed and monitored CAPA effectiveness, implementing timely actions based on investigation outcomes.
- Implementation of Good Laboratory Practices and cGMP compliance in department.
- Planning of regular activities and allotment of work to subordinates.
- Review and control of day – to- day activities within department.
- Interaction with all departments for day-to-day work activity and training to the QC personnel.
- Trained subordinates on effective troubleshooting methods.
- Conducted trainings to increase safety awareness among team members
- Working in quality control department and leading the QMS section.
Sr. Executive
MACLEOD LIMITED
Daman
03.2021 - 02.2023
- Review and approval of analytical reports of Semi-finished & finished Product, In-process, Process Validation samples and process performance qualification analytical data, protocol and reports.
- Conducted analysis of finished products, in-process samples, and process validation in quality control, including planning, data review, and batch release functions in LIMS software.
- Leading, coordinating investigations (Lab incident, OOS, OOT and deviation) in identifying root cause’s.
- Conducting investigations for out of specification, out of trend, laboratory incident and deviations in analytical aspects.
- Reviewed and created Quality Management System documents for OOS, OOT, and lab incidents, ensuring compliance and accurate record maintenance.
- Analyzed trends in incidents, OOT, and OOS, and provided training to QC team members based on these trends.
- Executed Quality Risk Management and implemented measures to minimize errors.
- Developed and tracked CAPA recommendations from investigations, ensuring timely implementation and effectiveness of actions based on results.
- Oversaw everyday activities to maintain efficiency and compliance in the department.
- Planned daily activities and assigned tasks to team members.
- Planning and making availability of resources in the department.
- Implementation of Good Laboratory Practices and cGMP compliance.
Sr. Executive
LUPIN LTD.
Aurangabad
03.2015 - 03.2021
- Conducted preparation and review of Quality Management System documentation such as OOS, OOT, lab incidents, change control, and deviations regularly.
- Prepared and reviewed investigation reports according to investigation evaluation score (IRES), ensuring compliance with current regulatory requirements.
- Conducted reviews of analytical documents, instrument audit trails, and stability summary data.
- Oversaw OOT activities and laboratory investigations, facilitating their prompt resolution.
- Conducting investigations for out of specification, out of trend, laboratory incident and deviations in analytical aspects.
- Responsible for review and approval of Standard Operating Procedure.
- Executed Quality Risk Management and addressed actions to minimize errors.
- Analyzed incidents, OOT, and OOS, and trained QC personnel according to the results of trending.
- Developed CAPA proposals from investigations and monitored their effectiveness, ensuring timely actions were taken based on results.
Jr. Executive
WOCKHARDT LTD.
04.2014 - 02.2015
- Managed GLP functions within the quality control department.
- Performed qualification and calibration of instruments.
- Oversaw the management of standards and columns.
- Performed qualification of standards and handled procurement.
- Addressed troubleshooting needs related to instruments in the quality control department.
- Handle analytical instruments like HPLC, GC, UV, Auto titrator, IR, Polarimeter, DT and friability.
Sr. Officer Quality Control
LUPIN LTD.
Tarapur
02.2013 - 04.2014
- Performed analysis on finished products, in-process samples, intermediate samples, and raw materials.
- Responsible for assay, related substance, water content, particle size, limit test and various chemical testing.
- Responsible for troubleshooting related to instrument in quality control department of routine analysis.
- Operated analytical instruments including HPLC, GC, UV, auto titrator, Malvern particle sizer, IR, and polarimeter to support quality control processes.
Quality Control Officer
BAJAJ HEALTH CARE LTD
Tarapur
02.2012 - 02.2013
- Analyzed finished product, stability, and raw material sections to ensure compliance with quality standards.
- Troubleshot instrument issues in quality control department, enhancing accuracy of routine analysis.
- Operated analytical instruments including HPLC, GC, UV, auto titrator, and IR to support quality assessments.
Quality Control Officer
AARTI INDUSTRIES LTD
Tarapur
08.2011 - 02.2012
- Analyzed finished product and raw material sections to ensure compliance with quality standards.
- Troubleshot instrument issues in quality control department, enhancing accuracy of routine analysis.
- Operated analytical instruments including UV, auto-titrator, IR, and polarimeter to support quality assessments.
Education
M.Sc. - Organic Chemistry
North Maharashtra University
Jalgaon, Maharashtra01-2011
B.Sc. - Chemistry
North Maharashtra University
Jalgaon, Maharashtra01-2009
Skills
- Regulatory compliance
- Quality management systems
- Good laboratory practices
- CAPA implementation
- Method validation
- Quality risk management
- Root cause analysis
- Analytical data review
- Strong investigation skills
Audit Experience
Working with the major formulation and Active Pharmaceutical Ingredients Manufacturing Companies approved by Regulatory bodies like USFDA, UKMHRA, ANVISA (Brazil), EUGMP, EDQM (Europe), WHO (Geneva) and TGA (Australia)., WHO, USFDA, MHRA, ANVISA, Different regulatory bodies, Domestic and CQA audit.
Software Knowledge
LIMS, Minitab, DMS, EDMS, QAMS, SABA, e-calibre track-wise, SAP, ERP, Empower 3.0, Chromeleon 6.8 & 7.2, Lab-solution/UV probe/UV Vis, Tiamo, Mastersizer, HPLC, GC, Dissolution, UV, Auto titrator, Malvern Particle sizer, Polarimeter
Current Designation
Manager
Languages
- English
- Hindi
- Marathi
Summary
Excelling in the Pharmaceutical field by working with growth-oriented organization where my knowledge, experience (About 15 years) and interpersonal skill can be valued and fully utilized for the growth of the organization. A confident individual seeking a challenging position in a reputed pharmaceutical company that will utilize my knowledge which is useful in Quality Department. Optimum utilization of knowledge to achieve higher responsibilities & be an active team player in organizational objectives achievements. Highly motivated, deadline-committed, goal-driven and proven track record of excellence., Quality Management System, Audit & Compliance, Documentation, Qualification and Calibration, Online trouble shooting
Personal Information
- Father's Name: Baburao Trymbakrao Nikam
- Notice Period: 3 Months
- Date of Birth: 03/04/89
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Websites
Timeline
Manager
PIRAMAL PHARMACEUTICALS LIMITED
09.2025 - Current
Assistant Manager
GLENMARK PHARMACEUTICALS LIMITED
02.2023 - 09.2025
Sr. Executive
MACLEOD LIMITED
03.2021 - 02.2023
Sr. Executive
LUPIN LTD.
03.2015 - 03.2021
Jr. Executive
WOCKHARDT LTD.
04.2014 - 02.2015
Sr. Officer Quality Control
LUPIN LTD.
02.2013 - 04.2014
Quality Control Officer
BAJAJ HEALTH CARE LTD
02.2012 - 02.2013
Quality Control Officer
AARTI INDUSTRIES LTD
08.2011 - 02.2012
M.Sc. - Organic Chemistry
North Maharashtra University
B.Sc. - Chemistry
North Maharashtra University