Brief Description of Working Environment Main functions are executed in WIP 1 and 2. The main equipment items in these areas are:
- Reactor Systems (3) with mixing and feed tanks.
- Filtration System 0,02 µ, 400 Da and 5000 Da
- Evaporation Plant
Main utilities include:
- Boiler
- Air Compressor
- Standby Generator
- Purified Water Plant (RO Plant)
- HVAC System
TYPICAL TASKS - Operate the reactor systems on a shift basis during primary manufacturing runs including night shifts;
- Coordinate and perform activities related to the purification and concentration of API, as per product requirements, according to GMP principles and in line with the company requirements and procedures;
- Regular (daily/weekly) inspection of utilities and completion of the related records;
- Regular (weekly/monthly) inspection of other equipment such as ladders and fire fighting equipment and completion of the related records;
- Service and maintenance of utilities;
- Ensure online QC and in-process controls are followed;
- Responsible for the cleaning of the department according to cleaning procedures, schedules or needs;
- Any other production or non-production related activities as required by the company.
- Ensure Food and Product Safety
KEY RESULT AREAS - Management of the performance of the purification and concentration processes
- Set targets for processes and measure,
- Ensure all materials are available for processes,
- Prepare SOPs according to actual processes and ensure that they are adhered to,
- Ensure that documents are completed in time and correctly,
- Ensure on time in full completion of final API batches.
- Optimization of the production processes and service utilities
- Ensure that equipment and machinery is in a good state of repair,
- Continuous improvement of processes.
- Occupational Health and Safety
- Ensure safety of personnel.
- Quality and Product Safety
- Hygiene and Housekeeping Standards/GMP
- Enforce discipline with regards to PPE,
- Operation according to GMP principles and guidelines,
- Cleaning practices and materials.
Minimum qualifications: Matric with relevant experience and/ or
Artisan - mechanical, electrical, electronic
At least 2 years as an operator in the food/pharmaceutical environment.
Specific knowledge: Unit processes
Legal requirements with regards to service utilities
Skills & ability: Attention to detail
Ability to lead
Team player
***Only shortlisted candidates will be contacted***
