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.

Skills Required