A well-known pharmaceutical organisation is seeking a Product Release Pharmacist to ensure 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

Key Job Outputs:

• Assume responsibility of the Responsible Pharmacist for batch release and acts as back up for Responsible Pharmacist in their absence
• Assist in auditing media fill documents
• Assist in compiling Annual Product Quality Reviews on all the organisation’s products
• Initiates batch related investigations for batch document audit findings and evaluates the CAPA on those investigations
• Provide in-house training as per ORP training programme

Batch Documentation Review for Active Biological Ingredient (ABI) and Final Product Release

• Fulfils the role of the 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

• 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 and/or Quality departments and escalated to the relevant manager
• Further, subsequently ensure that the required information or explanation has been provided, with the impact and/or risk 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 incorporated into the training programme

Initiate 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.
• Approval of recorded batch related notifications are performed cognisant of cGMP requirements
• 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 are met
• Institutes embargo transaction on product within the SAP notification system, when required
• Participate in investigations undertaken related to specific batches of product
• Ensures that, as far as possible, the root cause of problems is identified, quality risks have been identified and resolved
• Problems are fully investigated, prior to making decision regarding final product release or referring
• the batch to the Investigations and Batch Review Committee (IBRC) or the Technical Review
• Committee (TRC) for decision on product release
• Evaluation of corrective action implemented resulting from investigations undertaken or as a result of an
• incident or deviation in order to establish and ensure appropriateness of corrective action Institutes alternative corrective action if previous corrective action found to be inappropriate

Compile Annual Product Quality Reviews per Product

• Collate batch information and analyse information required for annual product quality review in accordance with the organisation procedure
• Compile and present the annual product review in accordance with predetermined plan to the required parties for signing in order to ensure that each product is reviewed
• annually
• Remain abreast with requirements related to annual product review and update documentation and the organisation system accordingly
• Provide in-house training as per ORP training programme
• Through batch manufacturing document audits, identify the areas that need improvement; tailor and deliver training to address these deficiencies
• Suggest training that needs to be undertaken by all staff to improve compliance

Assumes responsibility of the Responsible Pharmacist and acts as back up for Deputy Responsible Pharmacist in their absence

• Act as back up for the Deputy Responsible Pharmacist – This will be designated in writing by the Deputy Responsible Pharmacist
• Supervision of product release assistants and ORP Administrative Assistant

Competencies

• Attention to detail
• Initiative
• Good communication & interpersonal skills
• Analysis
• Tenacity
• Integrity
• Computer literate
• Ability to work independently with minimal supervision

Qualifications:

• B. Pharm
• Registered with SAPC

Experience:

• 2 years’ experience in a GMP-compliant environment preferable