Purpose of the position
- Preparing, reviewing, approving and distributing the instructions for theproduction of intermediates
or APIs according to written procedures;
- Producing Finished products according to preapproved instructions;
- to ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality;
- to follow the instructions relating to production operations and to ensure their strict implementation;
- Reviewing all production batch records and ensuring that these packaging processes are completed and signed;
- Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded;
- Making sure that production facilities are clean and when appropriatedisinfected;
- Making sure that the necessary calibrations are performed and recordskept;
- Making sure that the premises and equipment are maintained andrecords kept;
Evaluating proposed changes in product, process or equipment; and making sure that new and, when appropriate, modified facilities andequipment are qualified.
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Key responsibilities & duties
- Batch Document Creation & Use
- In-process Control, Line Clearance/Clean, Reconciliation, Retention samples
- GMP Training
- Pre-printed materials Usage & Reconciliation
- Change Control of Equipment, Facility & Documents
- Deviation & Non-conformance
- Reprocessing & Reworking
- Warehouse - Stock Management, Status Control, Dispatch, Maintenance & Housekeeping
Competencies sought: Supervising, Leadership, Goal achievement, Teaching / Instructing, Coping with deadline pressure, Flexibility, Ability to communicate.
Work experience and skills:
- Skills and knowledgerequired to comply with Good Manufacturing Practice (GMP) codes and workplace quality standards.
- Production Supervisor
