Production Pharmacist

2 weeks ago

Johannesburg, Gauteng, South Africa Isilumko Staffing Full time
We are looking for a P
roduction Pharmacist on a 4 months contract to:

  • Ensure that the Production facility operates in accordance with all the legal requirements as dictated by South African Health Products Regulatory Authority ("SAHPRA"), South African Pharmacy Council ("SAPC"), World Health Organisation ("WHO") and other regulatory bodies.
  • Planning which entails: Drafting of the monthly and weekly production schedule and ensuring that the plans are implemented efficiently and effectively as per schedules. Immunisation and bleeding schedule of the horses. Communicating requirements of the department to staff, assign duties and responsibilities.
  • To implement QA processes and SOPs in compliance with Good Manufacturing Practice [GMP] to ensure the production of safe, efficacious and quality products through: Compilation of SOPs and productionrelated documents to ensure compliance with the quality managemnet system.
  • Ensuring that the log book records and production documents are recorded and completed; Initiation and maintenance of SOP's and validation protocols, ensure update of SOPs. Training of the Operators on the contents of the SOP's To coach and develop the department's staff in order to ensure their understanding of SOPs and to keep them up to date with current GMP requirements
  • Processing which entails: Ensuring that Aseptic technique and cleanroom procedures are adhered to during processing.
Investigating causes of failure and implementing corrective action and prevention action ("CAPA") where necessary.

  • Responsible for line opening and closing during filling, packaging and inspection of antivenom. Ensure that packaging and processing instructions are adhered to.
  • Stock control: Ensure that the raw materials and packaging materials are ordered and that there is sufficient stock of each material when needed. Check and ensure that the raw materials are dispensed and weighed correctly.
  • To oversee and monitor equipment calibration and maintenance as per validation schedule to ensure avoidance of downtime
Liasing with external contracts to ensure the maintenance and validation schedule is adhered to.

  • To prepare & review annual production management reports to ensure that information is shared with other departments.
  • To manage assets [including Capex] and the procurement of consumables for seamless operation
  • To ensure that the department operates within OHSA requirements in order to maintain a safe workplace
  • Perform selfinspection Audits as part of a team and devise a plan to address the nonconformances
  • Responsible for Performance Management of all staff members in the department
  • Ensure that proper disciplinary procedures are followed when disciplining staff members.

Minimum requirements & key competency:

  • 4 year degree in Pharmacy [B. Pharm] (NQF Level 8)
  • Registration with South African Pharmacy Council as a Pharmacist
  • 6 years' experience in pharmaceutical manufacturing industry (inclusive of 1 year experience in Aseptic processing and 3 years in production)
  • Good understanding of Water systems, Autoclaves, HVAC systems etc
  • Knowledge of GMP requirements
  • Knowledge of aseptic techniques
  • Knowledge of sterilization methods
  • Knowledge of validations
  • Knowledge of OHSA
  • Basic financial knowledge
  • Computer literacy
  • General Management Skills
  • Communication skills
  • Interpersonal skills
  • Problem solving and trouble shooting skills
  • Attention to detail

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