Role Purpose
To safely and consistently perform tablet coating operations for potent products in compliance with cGMP, containment, quality, and EHS requirements, while ensuring operator safety, product integrity, and accurate documentation.
Key Roles & Responsibilities
A. Coating Operations
- Operate tablet coating equipment (auto coater perforated pan / appropriate coater models) for potent products as per approved BMR/BPR and SOPs.
- Execute tablet loading/unloading, coating solution preparation (as applicable), spray start/stop, drying, and cooling activities under defined parameters.
- Monitor and control inlet/outlet temperature, spray rate, atomization pressure, pan speed, and coating weight gain.
- Perform in-process checks (appearance, coating uniformity, weight gain, defects) and record results accurately.
- Handle and account for tablet rejects, fines, and yield reconciliation.
B. Potent Area & Containment Compliance
- Strictly follow high-potency handling, containment, and exposure control procedures.
- Use prescribed PPE and RPE (air suit / PAPR / respirator) as per area requirement.
- Ensure closed or controlled charging, spraying, and discharge to prevent exposure and cross-contamination.
- Adhere to gowning, de-gowning, and decontamination procedures without deviation.
C. Coating Solution Handling
- Prepare or support preparation of coating solutions/suspensions as per SOPs, ensuring correct order of addition, mixing time, filtration, and labeling (if applicable to role).
- Ensure correct identification, traceability, and usage time of coating materials.
- Follow spill control and safe handling practices for potent coating ingredients.
D. Equipment Cleaning, Changeover & Line Clearance
- Perform coater cleaning, decontamination, and validated changeover for potent products.
- Ensure line clearance before start and after completion of each batch.
- Verify and document equipment cleanliness and status labeling.
- Coordinate with maintenance for minor equipment abnormalities.
E. Documentation & cGMP Compliance
- Complete BMR/BPR, coating logs, IPQC records, cleaning records, and area registers in real time.
- Follow Data Integrity (ALCOA+) principles in all records.
- Comply with deviations, OOS/OOT support, change control, and CAPA processes as applicable.
- Support internal, customer, and regulatory audits with clear explanation of coating steps and controls.
F. Safety, EHS & Quality
- Comply with EHS guidelines, safety interlocks, alarms, and emergency procedures specific to potent coating.
- Immediately report spills, exposure risks, equipment malfunctions, or abnormal observations.
- Ensure proper segregation and disposal of potent waste, residues, filters, and cleaning effluents.
- Maintain high standards of housekeeping and 5S in the coating area.
G. Continuous Improvement & Teamwork
- Participate in Kaizen, OPLs, and process improvement initiatives.
- Support training and mentoring of junior operators.
- Coordinate with compression, IPQA, QC, EHS, and maintenance teams.
Qualifications Required
Educational Qualification
- ITI / Diploma in
- Pharmacy
- Chemical Engineering
- Mechanical / Electrical (with OSD pharma experience)
- 6-12 with relevant pharma manufacturing experience may also be considered.
