Executive - OSD Production

3 days ago

Daman Nagar Diu India SUN PHARMA Full time

Job Description Job Purpose To oversee and manage day-to-day production activities in the Oral Solid Dosage (OSD) manufacturing area, ensuring compliance with cGMP, USFDA, and other regulatory requirements while meeting production targets. Key Responsibilities - Supervise and execute production operations for granulation, compression, coating, and capsule filling. - Ensure adherence to batch manufacturing records (BMR) and standard operating procedures (SOPs). - Monitor in-process checks (IPC) and ensure compliance with quality standards. - Coordinate with QA, QC, Engineering, and Warehouse departments for smooth production flow. - Ensure proper documentation and compliance with USFDA, MHRA, and other regulatory guidelines. - Train and guide operators and technicians on GMP practices and safety protocols. - Participate in investigations of deviations, change controls, and CAPA implementation. - Monitor equipment performance and coordinate with maintenance for preventive and breakdown maintenance. - Ensure proper material reconciliation and yield monitoring. - Maintain hygiene and safety standards in the production area. Key Requirements - Education: B.Pharm / M.Pharm in a relevant field. - Experience: 5 7 years in OSD production in a USFDA/MHRA-approved facility. - Skills: - Strong knowledge of cGMP, GDP, and regulatory compliance. - Hands-on experience in granulation, compression, coating, and encapsulation. - Good documentation and communication skills. - Ability to handle audits and regulatory inspections. Preferred Qualifications - Experience with SAP or other ERP systems. - Exposure to regulatory audits (USFDA, MHRA, WHO, etc.). - Certification in GMP or production management is a plus.

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