Production Pharmacist

3 days ago

Johannesburg, South Africa Affirmative Portfolios Full time

**Medical / Emergency / Health ~ Health and Safety ~ Manufacturing**
**JHB East ~ JHB North**
***:
**Production Pharmacist - R833 891p/a (entry Level)**

**Sandringham - 4 Months Sessional / Locum Contract)**

**Responsibilities**

Ensure that the production facility operates in accordance with all the legal requirements as dictated by the South African Health Products Regulatory Authority (SAHPRA), South African Pharmacy Council (SAPC), World Health Organisation (WHO) and other regulatory bodies.

**Planning**
- Drafting of the monthly and weekly production schedule and ensuring that the plans are implemented efficiently and effectively as per schedule.
- Immunisation and bleeding schedule of the horses
- Communicating requirements of the department to staff, assign duties and responsibilities

**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 production related documents to ensure compliance with the quality management system
- Ensuring that the logbook records and production documents are recorded and completed
- Initiation and maintenance of SOPs and validation protocols, ensure update of SOPs
- Training of the operators on the contents of the SOPs
- To coach and develop the departments staff in order to ensure their understanding of SOPs and to keep them up to date with the current GMP requirements

**Processing**
- Ensuring that Aseptic technique and cleanroom procedures are adhered to during processing
- Investigating causes of failure to 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
- Liaising with external contracts to ensure the maintenance and validation schedule is adhered to.
- To prepare and 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 to maintain a safe workplace
- Perform self-inspection Audits as part of a team and devise a plan to adress the non-conformances
- Responsible for performance management of all staff members in the department
- Ensure that proper disciplinary procedures are followed when disciplining staff members

**Requirements**:

- 4-year degree in Pharmacy (B.Pharm) (NGF L8)
- Registration with South African Pharmacy Council as a Pharmacist
- 6 years’ experience in Pharmaceutical manufacturing industry (incl. 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 OHSA
- Basic financial knowledge
- Computer literacy
- Knowledge of sterilization methods
- Knowledge of validations
- General management skills
- Communication skills
- Interpersonal skills
- Problem solving and trouble shooting skills
- Attention to detail
- Basic financial knowledge

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