Process Controller Primary Production

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

• 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

• 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.
• Maintenance of systems
• 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:

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

Team player

***Only shortlisted candidates will be contacted***