Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide.
We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do.
The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.
The purpose of this role is to support the total Small Volume Parenteral production operation from a pharmaceutical perspective under direct supervision of a qualified Production Pharmacist.
Conversant with daily production program and schedule required pharmaceutical activities accordingly.
Identifies and addresses daily production problems
Reports / liaises daily with the production pharmacist and in case of absence with the department manager on the production situation.
Performs department pharmaceutical duties under the direct supervision of a qualified pharmacist
Is responsible for department productivity and loss control (labour, money, machines)
Support in the training of staff.
Assists the production pharmacist to write, review and update department Standard Operating Procedures and Good Manufacturing Practices.
Support production department that the daily production program and targets are met.
Capable of carrying out 'second line' management function for staff problems/disputes.
Responsible for the department compliance with factory rules and regulations.
Responsible for the maintenance of Good Manufacturing Practices Standards within the department.
Responsible for the accurate completion and reconciliation of departmental batch book documents.
Performs production compounding with mixing operator in line with batch record.
From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent.
Understand aseptic pharmaceutical manufacturing
Understand quality investigation requirements (risk assessments, deviations, change controls. ie Kabitrack)
Batch book documentation requirements
Understand SOP structure
Understand production planning process
Cleanroom gowning competence
Understand full manufacturing process
Accuracy/ Attention to detail
Planning
Prioritising
* SOP's according to Skills Matrix
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