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.
