Manufacturing Compliance Specialist

Responsibilities

• Support compliance activities within manufacturing 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 the initiation, tracking, and closure of Corrective and Preventive Actions (CAPAs) and manage change control activities.
• Assist with the documentation, tracking, and investigation of manufacturing deviations and Unplanned Deviations (UPDs).
• Track, monitor, and report training metrics to ensure personnel are qualified and current on required training.
• Maintain accurate and compliant records within quality management systems and support the creation or review of quality documentation.
• Support new equipment qualification activities and update 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 of 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 multitask and prioritize.

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.

About the Company

Sun Pharmaceutical Industries, Inc (USA) is a leading global pharmaceutical company dedicated to providing high-quality, affordable medicines to patients worldwide through innovation and excellence in manufacturing and quality.