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Process Manager Primary Production

2 months ago

Stellenbosch, South Africa Adzuna ZA B C2 Full time
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.
  • 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:

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***