NIKUNJ PANCHAL
Sohar,MA
Summary
Accomplished Quality Assurance and Regulatory Affairs Manager with extensive experience at Drug Manufacturing Company LLC. Expert in risk management and audit compliance, driving significant process improvements. Proven leader skilled in statistical analysis and project management, ensuring adherence to regulatory standards while enhancing product quality and operational efficiency.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Quality Assurance and Regulatory Affairs Manager
Drug Manufacturing Company LLC
Sohar
03.2025 - Current
- Role of the lead auditee during external (customer and regulatory) audits.
- Responsible for providing the requested information to auditors and visitors.
- Developed and implemented quality assurance policies and procedures.
- Evaluation of supplier performance against pre-defined criteria and negotiated contract terms, accordingly.
- Providing guidance on process improvements and best practices in order to maintain high levels of product quality.
- Coordination with other departments, such as engineering, manufacturing, and sales, in order to resolve any issues related to product quality.
- Performed root cause analysis on non-conforming materials or products in order to determine appropriate corrective actions.
- Trained and mentored project leaders to drive culture change toward a total quality mindset across production activities.
- Preparation, review, and approval of SOPs, validation protocols, and reports.
- Preparation, review, execution, and approval of all validation programs like process validation, cleaning validation equipment qualification, facility (HVAC and water system), instrument and equipment qualification.
- Responsible for development of vendors through vendor qualification and supplier qualification procedure followed by executing a vendor and supplier audit.
- Review MIS report (Management Information System), Annual product quality review, Site master file, Validation master plan, Continuous process verification protocol/report & all quality impacted documents for their compliance with current GMP.
- Review & approval of executed batch manufacturing and laboratory control records before the release of the API, intermediates for distribution/ dispatch.
- Review & approval of stability data / Holding time data to support retest or expiry dates and storage conditions of the Intermediates/ API.
- Responsible to conduct Internal audit (Self-inspection) as per schedule and verification of its compliance & investigation of the market complaint/return goods/ Recalls.
- Handling of Out of specifications, Out of trend, Laboratory Incident, Deviation and Change Control.
- Involvement in preparation and submission of regulatory supportive documents for preparation of Certificate of suitability, Drug Master File, and its Annual Updates.
- To ensure that the premises and equipment are maintained & preventive maintenance/calibration are carried out as per schedule.
- Responsible for releasing or rejecting finished products, intermediates, raw materials, and packing materials.
- Conducting training on current good manufacturing practices and Good laboratory practices, SOPs, and validation. (process, cleaning, and analytical method validation).
- Ensuring all other relevance tasks which may impact to product quality.
- All relevant tasks assigned by management of the company.
- Brief knowledge of purified water systems and environmental monitoring.
- Responsible to review and approve risk management reports, nitrosamine report and genotoxic assessment reports.
- Responsible for Regulatory fillings and provide timely compliances to regulatory agencies.
- Having knowledge of ICH, USFDA, EDQM, Schedule M, ISO 9001, 21CFR and WHO guidelines.
Quality Assurance Manager
Alcon Biosciences pvt LTD
Vapi
06.2022 - 02.2025
Quality Assurance manager
Oriental aeromatics LTD
Vadodara
05.2022 - 06.2022
Assistant Manager
Alembic Pharmaceuticals LTD
Vadodara
11.2015 - 05.2022
Officer
Lupin LTD
Vadodara
05.2014 - 11.2015
Officer
IPCA laboratories LTD
Vadodara
09.2013 - 05.2014
Executive
Torrent pharmaceuticals LTD
Ahmedabad
06.2012 - 09.2013
Education
MBA - Operation Management
Parul University
Vadodara, India01-2026
Master of Science - Chemistry
Gujarat University
Ahmedabad, India05.2012
Bachelor of Science - Chemistry
Gujarat university
Dahod, India05.2010
Skills
- Risk management
- Audit and compliance
- Statistical analysis
- Time punctuality
- Leadership
- Decision-maker
- Project management
Personal Information
- Date of Birth: 01/31/1989
- Nationality: Indian
- Passport Number: V8662014
Certification
- ISO 9001:2015 certified lead auditor from TUV SUD Asia, Pvt. Ltd.
Languages
English
First Language
Hindi
Proficient (C2)
C2
Gujarati
Proficient (C2)
C2
Audit Exposure
- USFDA
- EDQM
- TGA
- CDSCO
- KFDA
- TGA
- Customer's audits
Electronic software's exposure
- Caliber QMS
- SAP
- ERP
- LIMS
- Documentum
References
References available upon request.
Timeline
Quality Assurance and Regulatory Affairs Manager
Drug Manufacturing Company LLC
03.2025 - Current
Quality Assurance Manager
Alcon Biosciences pvt LTD
06.2022 - 02.2025
Quality Assurance manager
Oriental aeromatics LTD
05.2022 - 06.2022
Assistant Manager
Alembic Pharmaceuticals LTD
11.2015 - 05.2022
Officer
Lupin LTD
05.2014 - 11.2015
Officer
IPCA laboratories LTD
09.2013 - 05.2014
Executive
Torrent pharmaceuticals LTD
06.2012 - 09.2013
MBA - Operation Management
Parul University
Master of Science - Chemistry
Gujarat University
Bachelor of Science - Chemistry
Gujarat university
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