Production Pharmacist

1 week ago


Port Elizabeth, Eastern Cape, South Africa Fresenius Kabi Full time R900 000 - R1 200 000 per year

To co-ordinate the total Large Volume Parenteral filling production operation from a pharmaceutical perspective.

Duties:

§ Is conversant and well versed with daily production program.

§ Identifies and addresses daily pharmaceutical problems.

§ Reports / liaises daily with the Department Manager on the pharmaceutical (production) situation.

§ Performs department pharmacy duties.

§ Assist the Production Leaders to ensure that all staff is properly trained for their job.

§ Writes, reviews up-dates department Standard Operating Procedures and Good Manufacturing Practices.

§ To support production department in ensuring that the daily production program and targets are met.

§ 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.

§ Assist the Department Manager with the close out of Deviations, CAPA's audit findings etc.

§ Responsible for the implementation of change controls.

§ Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack.

§ Will be required to stand in for Production Leaders in the event of training or absenteeism etc.

§ Supervision and training of pharmaceutical staff.

§ From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent.

Competence Requirements:

  • Understand LVP production processes

  • GMP Principles

  • Understand quality investigation requirements (risk assessments, deviations, change controls ie. Kabitrack)

  • Risk evaluation and documentation

  • Interpret and apply production plan

  • Batch book documentation and auditing requirements

  • Logbook and area compliance

  • Root Cause Analysis

  • Health and Safety compliance

Understand process for entering Grade C and D areas

  • B Pharm Tertiary qualification.

  • Registered Pharmacist with South African Pharmacy Council.

  • Pharmaceutical manufacturing experience.

  • Proven 'hands – on' managerial ability

  • Production management skills

  • Specific Large Volume Parenteral process technical skills

  • Human resources / industrial relations skills

  • N.O.S.A and MOSACT awareness

  • 1 year experience minimum


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