Manufacturing Compliance Specialist

Responsibilities

• Support compliance activities within the manufacturing organization to ensure adherence to internal procedures, regulatory requirements, and quality standards.
• Coordinate with cross-functional departments including Manufacturing, Quality Assurance, Engineering, and Training to support compliant operations.
• Act as a compliance liaison for manufacturing activities, ensuring timely communication and issue resolution.
• Support manufacturing readiness for audits, inspections, and internal reviews.
• Track, monitor, and report training metrics to ensure personnel are qualified and current on required training.
• Support the initiation, tracking, and closure of Corrective and Preventive Actions (CAPAs) related to manufacturing.
• Assist with change control activities impacting manufacturing processes, equipment, documentation, and materials.
• Support documentation, tracking, and investigation of manufacturing deviations and Unplanned Deviations (UPDs).
• Maintain accurate and compliant records within quality management systems.
• Update and maintain Master Batch Records (MBR) to reflect process changes.
• Ensure compliance with cleanroom requirements, including gowning and environmental controls.

Requirements

• High School Diploma required (B.S. in a related field preferred).
• Minimum 3 years of related experience supporting Manufacturing or Quality Departments.
• Working knowledge of GMP, quality systems, and regulatory requirements.
• Experience supporting CAPAs, change controls, and deviation management.
• Proficient in documentation systems and basic data tracking/reporting tools.
• Strong organizational and coordination skills with the ability to manage multiple priorities.

Preferred Qualifications

• Experience in pharmaceutical, biotech, medical device, or other regulated manufacturing environments.
• Familiarity with electronic Quality Management Systems (e.g., TrackWise, EDMS, MasterControl).
• Experience tracking training compliance metrics.
• Knowledge of root cause analysis tools and continuous improvement practices.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Life insurance and disability insurance.
• 401(k) savings plan.
• Flexible spending accounts and employee assistance program.
• Paid time off, including vacation and sick time.

About the Company

Sun Pharma is a leading player in the generics market in the U.S. and is rapidly expanding its presence in the specialty branded market, focusing on dermatology, ophthalmology, and oncology. We foster an inclusive and collaborative work culture where employees are empowered to pursue their professional aspirations.