Process Manager Primary Production

SUMMARY:
Reporting to the Operations Manager you will assist in the manufacture of Raw Active Pharmaceutical Product (API) during production runs and take control of all activities related to the purification and concentration of API. Responsible for the efficient operation and maintenance of all service utilities.

POSITION INFO:
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

• 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 SOP’s 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.