Pharmaceutical Production Operator

Position Overview:
The role of a Pharmaceutical Production Operator involves a diverse range of activities. These activities may include;
1. Handling of materials,
2. Assembly, set up and operation of pharmaceutical equipment such as the spray dryers, blending,
capsule filling, blister packing and secondary packaging equipment to produce the finished product.
3. Equipment cleaning and sanitising.
4. Completion of documentation associated with production tasks- batch records, cleaning forms,
inventory forms etc.
5. Cleanroom cleaning and housekeeping.
6. Participating in the secondary packaging process.

Materials -
1. Handle and label materials appropriately and with care as detailed in SOPs.
2. In-process sampling according to procedure.
3. Enter consumption and output data into Navision, the Enterprise Resource Planning database system.
4. Ensure only approved materials are used (unless otherwise advised).
5. Store materials appropriately.
6. Assist in warehouse operations; carry out incoming goods receiving and product dispatch operations
as required.
7. Identify and report to Supervisor any irregularities, incidents etc. associated with materials.

Operation and Maintenance of Equipment -

1. Set-up and operate production equipment.
2. Ensure production equipment operates within predetermined parameters.
3. Execute routine maintenance of equipment as required.
4. Perform equipment cleaning as required to meet cGMP regulations.
5. Participate in and perform experimental trials/development work to improve or correct processes.
6. Trouble-shooting of equipment.
7. Participate in secondary packaging operations when required.

Documentation -
1. Review procedures and processes. Contribution to procedures may be required.
2. Read updates to documentation as required and implement updates in relevant process.
3. Ensure batch document paperwork is signed and completed to meet cGMP requirements.
4. Partake in risk assessments and investigations where required.

Clean-room -
1. Ensure the clean room and storage area are kept clean and free of defects. Complete scheduled
cleaning and supervise contract cleaners when required.
2. Ensure the pressure differentials; temperature, relative humidity and the status of the room are
compliant prior to commencing manufacture of a batch.
3. Avoid causing excursions in cleanroom/warehouse environmental conditions (e.g. blocking vents,
introducing foreign particles to area etc.).
4. Environmental monitoring of the cleanroom i.e. particle count monitoring.
5. Supervise visitors/contractors upon entry to the Clean Room.

Safety Compliance -
1. Ensure all work is performed in a safe manner in accordance with the Arnapharma OH&S policy and
specific procedures.

Training -
1. To conduct on the job training and formal training of others in cleanroom procedures were necessary.
Complete regular GMP training as instructed.

GMP -
1. All Operators are trained in specific processes, which incorporate good manufacturing practice. Each
Operator is responsible for following these procedures and carrying out activities in a GMP compliant
manner.
2.Operators are obliged to report and compliance issues, incidents etc. to Production Senior
Management so effective and precise corrective actions can be taken immediately