Product Release Pharmacist

Job Advert Summary

Guided by its purpose to provide products for patients to alleviate pain and suffering and improve their quality of life, NBI’s vision is to be the leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products.

National Bioproducts Institute NPC has a vacancy for the role of Product Release Pharmacist. The successful incumbent will be responsible for:

• Ensuring that all batches of product released for sale comply with cGMP and regulatory requirements as well as being of the required safety, quality and efficacy.
• Assuming responsibility of the Deputy Responsible Pharmacist for batch release and acts as back up for Responsible Pharmacist in their absence.
• Conducting annual product quality review on all NBI products.
• Ensuring that the notification system for batch related problems is correctly managed.
• Initiates batch related investigations and evaluates the CAPA on those investigations.
• Providing in-house training as per O.R.P training programme. Applications are invited from suitably qualified and experienced candidates.

• The successful candidate will be required to work an 8 hour shift as rostered between 14:00 to 22:00 Monday to Friday.
• Candidate must have access to reliable transport.
• May be required to work overtime to meet the business needs.
• Must be prepared to work shifts/weekends/public holidays when needed.

• BPharm
• Registered with SAPC
• 2 years experience in a Pharmaceutical manufacturing environment
• Experience in an ISO approved environment preferable

Batch documentation review for final product release

Fulfils the role of the Deputy Responsible Pharmacist for final product release by the evaluation and interpretation of all production documentation. Evaluates batch notifications in order to establish compliance with validated parameters and company procedures to make a decision regarding product safety, quality and efficacy prior to processing final release of the product on SAP. This includes ensuring that:

• All required information on the batch manufacturing record has been provided
• The evaluation of batch rejects has shown no unusual/unacceptable/unexplained result.
• Required incidents and deviations have been recorded and all tasks have been completed in SAP and notification has been marked with the appropriate status.
• All recorded data is within the required specification; if it is not adequate, an explanation has been provided
• All operations took place within the required parameters and were appropriately authorised
• Evaluation of environmental monitoring results prior to product release ensuring that results that are OOS do not have an impact to Safety, Quality and Efficacy of the batch.
• Determining that any deficiency noted above has been addressed with production or escalated to the relevant manager and the required information or explanation subsequently has been provided, with the impact of omission evaluated prior to batch release.
• Assists in maintaining a system that ensures traceability of information when destruction of batch has taken place. Ensuring that certificate of product failure is completed and that certificate of destruction is obtained from destruction company and filed with relevant batch document.
• Evaluation of rejects from produced batches in order to detect if there are trends developing, investigate any unusual reject rate, and implement action plans and corrective action to reduce reject rates after investigation into cause. Ensure that operator training required to reduce reject rate is fed into the training programme.

Instigate batch related investigations, as required

• Assists in the management of SAP notification system to ensure that:
• All incidents and deviations in the organisation are fully documented ensuring integrity and completeness of information
• All tasks are completed in a timely manner.
• Responsible for GMP approval of recorded batch related notifications
• Incidents and deviations are recorded at the time the event occurs or soon thereafter, as far as is reasonably practicable
• Suggests and implements enhancements to ensure quality objectives…