KEY RESPONSIBILITIES

 Operational efficiency

• Contribute to the creation and implementation of best practice processes and procedures to aid and improve operational performance and timeous release of product to market.
• Contribute to timeous implementation of QA projects.

Operational activities

• Conduct, manage and coordinate batch release reviews and approve final product release to the market as per the legal requirements and guidelines set by SAHPRA and the Department of Health, and in line with the registered dossier.
• Always maintain and coordinate all the GMP principles as required by the SAHPRA as stipulated in the latest version of the SAHPRA / PIC/S (Pharmaceutical Inspection Co-operation Scheme) guidelines for cGMP and related systems and procedures to ensure compliance.
• Liaise and coordinate with relevant 3rd parties to ensure all pre-requisites are available to action a product release.
• SAP releasing and processing, including but not limited to batch creation and amendments.
• Ensure direct communication and continuous pursual of achieving annual plans and schedules (including but not limited to annual stability plan, annual product quality review schedule, Quality Agreement renewals, annual audit plan, departmental training plans).
• Liaise and communicate any anomalies, non – compliances and discrepancies to the rest of the team and assist with deviations and investigations.
• Ensure accurate capture of data across all electronic platforms.
• Assist with any product related GMP activities, including but not limited to stability, annual product quality reviews, quality agreements, audits and risk assessments.
• Review of executed Batch Manufacturing documents received from 3rd parties.
• Assist in product recalls/mock recalls.
• Ensure Head office sample storage is accurately controlled and ensure S6 and SS5 registers remain balanced at all times.
• Maintain in-house documentation relating to QA processes, ensuring compliance with current SAHPRA licensing conditions for import and export functions (procedures, forms, registers, records and reports).

Review and monitor the below but not limited to: 

• Product change control process
• Issue log (Including deviations, CAPAs, change control process, Investigations
• Destructions
• Risk Assessments
• Internal QMS documents: SOPs, forms, registers and records
• Temperature monitoring during transportation.

General

• Perform any other duties as per changes in operational requirements of the department.
• Perform any other duties as required.

Requirements

 PRE-REQUISITES

• B. Pharm registered with the SA Pharmacy Council.
• Minimum of 2 years Quality Control or Quality Assurance hands-on experience within the pharmaceutical industry.
• Knowledge of the quality environment within the pharmaceutical industry.
• Working knowledge of cGMP and the maintenance of Quality Management Systems.
• Working knowledge of the requirements and process of batch release to the market.