Education:
Bachelor of Pharmacy Degree
Registered with the South African Pharmacy Council
Minimum of 2 years manufacturing experience in a similar environment
Ensure that all activities are carried out in compliance with the Pharmacy Act and all other relevant Acts and to ensure that our Product Quality reviews are completed as per Industry Standards and timeous release of the product to the market.
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 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 organisation
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
