Group Quality and Compliance Associate

6 days ago

Durban North, South Africa Aspen Pharma Group Full time

Job Purpose : This role will support the implementation and monitoring of the Group Quality Management System, ensuring compliance with regulatory requirements and pharmaceutical best practices. Maintain Group Quality policies and procedures and provide training to all Aspen Affiliates. Develop and manage Group Quality Awareness programs to ensure or improve Affiliates’ compliance status. Key Performance Areas : Group Quality Governance Develop and maintain Group Quality policies and procedures aligned with the regulatory GMP requirements and minimum Group Standards and provide training to all Aspen Affiliates. Define the minimum QMS standards required at the Aspen affiliate via Group Policies or Guidance. Develop and manage Group Quality Awareness programs to ensure or improve Affiliates’ compliance status. Establish KPIs to monitor Aspen Affiliates' QMS. Monitoring and Continuous Improvement Manage and monitor the Group Audit Program for Aspen Affiliate. Manage the Aspen Affiliates Audit Schedule and liaise closely with GOQC to ensure that Aspen Affiliates are audited according to the schedule. Inform GOQC if the need for a cause audit arises and what the timeframe is. Provide pre-audit documentation to the auditor. Monitor and work with the Aspen Affiliates to close the CAPA records related to the audit findings. Maintain the Working Practice between Group Compliance and GOQC, defining the requirements and responsibilities for audit for Aspen Affiliates. Monitor the implementation and compliance with GQMS standards across all regional affiliates as well as Holdings' core functions, ensuring that each Affiliate Marketing Authorisation Holding (MAH) entity, defined non-MA holding entity, and those that provide essential support to the Aspen MAH. Implementation of QMS at APHL Implement and enhance the overall QMS in APHL. Roll-out of QMS for key departments with a direct impact on Group Products and the management thereof. Maintenance of Standard Operating Procedures (SOPs) following the defined structure, review of SOPs from other departments Ensure that training requirements relating to APHL SOPs are included in the training plans of the relevant departments. Manage the GMP process in APHL, Durban, e.g., change controls, deviations, CAPA, self-inspection. Established processes in compliance with GMP requirements. Develop and enhance ways of working and processes within APHL. Monitor APHL QMS through KPIs. System SME Support the implementation of the Digital Quality System #J-18808-Ljbffr

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