Role Overview
Supervise and oversee all compression operations in a US FDAapproved Oral Solid Dosage (OSD) manufacturing plant. Ensure tablet compression lines meet cGMP, FDA standards, and production goals.
Key Responsibilities
- Supervise daily tablet compression operations as per cGMP and FDA guidelines.
- Manage and allocate manpower across shifts for smooth production.
- Ensure compliance with SOPs, batch records, and regulatory requirements.
- Monitor in-process checks (weight, hardness, thickness, friability) and resolve deviations.
- Oversee equipment setup, cleaning, and preventive maintenance.
- Coordinate with QA/QC for line clearance and documentation accuracy.
- Handle changeovers and ensure timely completion of production schedules.
- Train and guide operators on equipment handling and safety protocols.
- Maintain housekeeping and safety standards in compression area.
- Prepare daily production reports and escalate issues to management.
Qualifications
- Bachelor's in Pharmacy or related field.
- 35 years experience in OSD compression; 12 years in supervisory role.
- Strong knowledge of cGMP, FDA 21 CFR Part 211, and data integrity principles.
- Leadership, problem-solving, and documentation skills.
