Operator

Role Objective / Major Purpose of the Job
Responsible for compounding, preparing, and homogenizing the inner medicinal fill material (solution,
suspension, or paste) that goes inside softgel capsules. They ensure the active pharmaceutical ingredients
(APIs) and excipients are mixed according to strict cGMP guidelines
Principal Tasks & Responsibilities
1. Medicament Preparation: Operate compounding vessels, high-shear mixers, and homogenizers to prepare
the active liquid, suspension, or paste fill.
2. Process Parameters: Monitor and control mixing speeds, heating/cooling water jackets, vacuum levels, and
homogenization times.
3. De-aeration: Run vacuum systems on compounding tanks to completely remove air bubbles from the
medicament fill prior to encapsulation.
4. Daily Production Planning: Execute daily preparation schedules provided by the supervisor to keep up with
the encapsulation line demands.
5. Line Clearance: Perform and document complete room, vessel, and transfer line clearance steps before
starting any new product batch.
6. Yield Monitoring: Weigh raw APIs and excipients, and track final medicament weight to calculate preparation
yield and minimize active material loss.
7. In-Process Quality Tests: Check and record critical parameters such as viscosity, pH, particle size, and density
of the prepared fill solution.
8. BMR Log Entries: Fill out the Batch Manufacturing Record (BMR) and vessel logbooks accurately and in real-
time.
9. Vessel Cleaning (CIP/SIP): Clean, sanitize, and sterilize transfer pumps, colloid mills, mixing vessels, and
holding tanks to prevent batch-to-batch contamination.
10. Safe Working: Wear mandatory PPE (including respirators, chemical gloves, and eye protection) when
handling raw active powders and hot liquids.

Key Skills & Competencies
Functional / Technical:
Operation of jacketed compounding tanks, vacuum pumps, colloid mills, moisture testing tools, and managing liquid
transfer lines under nitrogen or air pressure.
Behavioural:
1. High precision in weighing and tracking chemical ingredients, strict discipline, and immediate reporting of any
mixing deviations to the supervisor.
2. Discipline & Punctuality: Arrives on time for shift handovers and maintains clean room discipline throughout
the day.
3. Teamwork: Works smoothly with fellow operators, helpers, and maintenance technicians to finish batches
faster.
4. Clear Communication: Speaks up instantly to report machine sounds or process mistakes to the supervisor.
5. Safety Awareness: Stays highly alert to electrical lines, and moving machine parts on the floor.