Duties and responsibilities

• Ensure that all activities are carried out in compliance with the Pharmacy Act, Medicines and Related Substances Act 101 of 1965 and other pertinent laws and regulations.
• To ensure compliance to all aspects of cGMP, cGWP and cGDP.
• To ensure compliance to SAPC at all times.
• To be responsible for COA and Batch review.
• To ensure timely, efficient and responsible release of product.
• To ensure that retention samples are stored and handled appropriately.
• Sending samples off to the laboratory for post importation testing and ensuring timeous receiving of results.
• To assist with post-importation exemption renewals.
• Ensure that deviations are reviewed timeously.
• To assist in the control and execution of change controls.
• To ensure that Product Quality reviews are completed as per SOP.
• To assist in the training of relevant Quality Assurance SOPS within the organization.
• Review of artwork.
• To ensure that stability protocols are in place and product is placed on stability accordingly.
• Maintenance of Schedule 5 cage including picking of schedule 5 products and maintenance of schedule 5 register.
• Compiling reports and control of expired and damaged products for waste removal.
• To register all technical and ADR complaints.
• To trend all technical and ADR Complaints.
• Training of sales/marketing and customer service staff on complaint handling.
• Ensure that investigation reports are received and logged for the complaints received.
• Ability to handle a recall according to the correct procedure.
• Ensure compliance with the NRCS.

Professional competencies

• BPharm tertiary qualification.
• Registered with the South African Pharmacy Council.
• Minimum of 2 years manufacturing experience in a similar environment.

Personal competencies

• Results driven.
• Meticulous attention to detail.
• Excellent problem solving skills.
• Ability to manage time effectively.
• Deadline driven.