Sanjay Chavda
Dayton
Summary
Pharmaceutical manufacturing expert skilled in cGMP compliance and production supervision, dedicated to achieving operational excellence. Proven track record in equipment qualification and process optimization, fostering continuous improvement.
Overview
14
14
years of professional experience
Work History
Production Supervisor
Amneal Pharma
Piscataway
12.2024 - 10.2025
- Supervised daily production operations to ensure compliance with safety regulations.
- Coordinated workflow among team members, meeting production schedules consistently.
- Trained new employees on proper equipment usage and adherence to safety protocols.
- Monitored equipment performance and reported maintenance needs without delay.
- Assisted in inventory management and material handling processes.
- Communicated effectively with management regarding production issues.
- Led team meetings to discuss objectives and address concerns efficiently.
- Maintained accurate records of daily production activities.
- Trained new staff on production processes and procedures.
- Communicated effectively with other departments to ensure smooth workflow from start to finish.
- Delegated tasks to employees and monitored accurate and timely completion of tasks to meet project milestones.
- Monitored inventory levels and ordered materials as needed to maintain production operations.
Manufacturing Associate III
NJ Bio Pharmaceuticals
Princeton
07.2024 - 12.2024
- Ensured compliance with standard operating procedures to uphold product integrity and quality assurance.
- Maintained organized work areas to enhance safety in production environments.
- Collaborated with team members to consistently meet production targets.
- Executed comprehensive batch manufacturing records from initial scaling through commercialization.
- Reviewed validation protocols for compliance with 21 CFR Part 210 and 211 regulations.
- Created and revised standard operating procedures and master batch records as needed.
- Participated in equipment qualification efforts through installation, operation, and performance qualifications.
- Conducted process and cleaning validations to ensure operational reliability.
Production Supervisor
Apnar Pharma
East Windsor
06.2022 - 04.2024
- Planned production operations by establishing priorities and sequences for manufacturing processes.
- Maintained accurate records of daily production activities for transparency.
- Verified completed batch records and supporting documents for compliance.
- Performed documentation reviews of manufacturing and packaging batch records per SOP requirements.
- Initiated revisions of Batch Manufacturing Records (BMR) and Packaging Records (BPR).
- Supported equipment qualification (IQ/OQ/PQ) activities on manufacturing lines.
- Monitored inventory levels and ordered materials to sustain production needs.
- Participated in process validation, cleaning validation, and commercial stability studies.
Process Technician
Hovione
East Windsor
05.2020 - 09.2021
- Ensured compliance with safety standards by monitoring production processes consistently.
- Trained new team members on EHS, GDP, and production documentation practices.
- Accurately documented process changes while maintaining comprehensive production records.
- Supported drug product formulation projects through development and manufacturing assistance.
- Conducted thorough reviews of documentation and labeling as per SOP guidelines.
- Verified accuracy of completed batch records alongside cleaning verifications for equipment.
- Executed line clearance procedures while checking cleaning verifications for workspaces.
- Assisted in equipment qualification tasks to facilitate process validation.
Quality Associate
Aurex Laboratories LLC
East Windsor
04.2016 - 04.2020
- Conducted thorough quality inspections to ensure regulatory compliance of pharmaceutical products.
- Executed inspections of final products against Acceptable Quality Level standards.
- Oversaw review processes for documentation and labeling per established SOPs.
- Monitored production lines, consistently upholding safety and quality protocols.
- Verified compliance of batch manufacturing records and SOPs through detailed reviews.
- Sampled raw materials and finished goods following AQL criteria for quality assurance.
- Performed line clearances and equipment cleaning verifications effectively.
- Led facility-wide internal audits to confirm adherence to cGMP standards.
Manufacturing Production Technician
Heritage Pharmaceuticals
East Brunswick
03.2014 - 04.2016
- Executed Soft Gelatin Product Manufacturing for commercial applications.
- Performed documentation and labeling in accordance with required SOPs.
- Conducted BMRs from scale-up to commercial production phases.
- Completed in-process checks, including shell moisture, seal thickness, LOD, disintegration, and hardness.
- Supported equipment qualification and cleaning verification processes.
- Inspected finished products for defects or discrepancies prior to shipment.
Manufacturing Technician
Aspire Pharmaceuticals
Somerset
10.2011 - 03.2014
- Executed soft gelatin product manufacturing for commercial applications.
- Operated and maintained robotic capsule production machinery to ensure efficiency.
- Conducted documentation and labeling according to standard operating procedures.
- Troubleshot production equipment, significantly reducing downtime.
- Performed quality checks on weight, seal thickness, and ribbon thickness to meet specifications.
- Managed and scheduled production activities for batch manufacturing and processing.
Education
Bachelor of Science - Chemistry
Gujarat University
Gujarat, India05-2011
Skills
- Compliance with safety regulations
- Scheduling production activities
- Management of inventory systems
- Leadership in team environments
- Review of batch records and documentation
- Training and mentoring employees
- Qualification of equipment and validation processes
- Proficiency in Microsoft Office applications
- Development of standard operating procedures
- Preparation and review of SOPs, BMRs, BPRs
- Adherence to cGMP and GDP standards
- Execution of IQ, OQ, PQ protocols
References
References available upon request.
Timeline
Production Supervisor
Amneal Pharma
12.2024 - 10.2025
Manufacturing Associate III
NJ Bio Pharmaceuticals
07.2024 - 12.2024
Production Supervisor
Apnar Pharma
06.2022 - 04.2024
Process Technician
Hovione
05.2020 - 09.2021
Quality Associate
Aurex Laboratories LLC
04.2016 - 04.2020
Manufacturing Production Technician
Heritage Pharmaceuticals
03.2014 - 04.2016
Manufacturing Technician
Aspire Pharmaceuticals
10.2011 - 03.2014
Bachelor of Science - Chemistry
Gujarat University