SUMMARY:
Our client, a leading African manufacturer and supplier of quality products, currently seeks a qualified and experienced 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.
POSITION INFO:
About the Role:
- Assume responsibility of the Responsible Pharmacist for batch release and act as back up for Responsible Pharmacist in their absence.
- Assist in auditing media fill documents.
- Assist in compiling Annual Product Quality Reviews on all products.
- Initiate batch related investigations for batch document audit findings and evaluate the CAPA on those investigations.
- Provide in-house training as per ORP training programme.
The Person:- B. Pharm essential.
- Must be Registered with SAPC.
- Min 2 years’ experience in a GMP-compliant environment pref.
The Job:Report to the Product Release Authorisation Manager:
- Final product release by the evaluation and interpretation of all production documentation.
- Evaluate 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:
- All required information on the batch manufacturing record has been provided.
- Evaluation of batch rejects to ascertain unusual/unacceptable/unexplained results.
- Required incidents and deviations recorded and all tasks 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 take place within the required parameters and are 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.
- Determine that any deficiency noted above has been addressed with Production and/or Quality departments and escalated to the relevant Manager.
- Assist in maintaining a system that ensures traceability of information when destruction of batch has taken place.
- Evaluate 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 investigating causes.
- Ensure that Operator training required to reduce reject rate is incorporated into the training programme.
Initiate Batch Related Investigations:- Assist 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.
- Approval of recorded batch related notifications are performed cognisant of cGMP requirements.
- Incidents and deviations are recorded at the time the event occurs.
- Suggest and implement enhancements to ensure quality objectives are met.
- Institute embargo transaction on product within the SAP notification system, when required.
- Participate in investigations undertaken related to specific batches of product.
- Ensure that, as far as possible, the root cause of problems is identified, quality risks have been identified and resolved.
- Investigate problems prior to making decision regarding final product release or referring the batch to the Investigations and Batch Review/Committee or the Technical Review Committee for decision on product release.
- Evaluate 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.
- Institute alternative corrective action where necessary.
Compile Annual Product Quality Reviews per Product:- Collate batch information and analyse information required for annual product quality review in accordance with company procedures.
- 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 company system accordingly.
- Provide in-house training.
- 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.
Act as back up for Deputy Responsible Pharmacist:- Supervise Product Release Assistants and ORP Administrative Assistant.
Competencies:- Attention to detail.
- Analysis.
- Performance management.
- Lead and influence others.
- Manage relationships.
- Initiative.
- Good communication & interpersonal skills.
- Tenacity.
- Integrity.
- Ability to work independently with minimal supervision.
NB! This job is now closed. You can apply for other jobs by uploading your CV.
