Group Quality and Compliance Associate

Aspen Pharma Group; Durban North; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Manager to oversee the implementation and monitoring of the Group Quality Management System at their Durban location. This role involves maintaining quality policies, providing training to affiliates, and ensuring adherence to regulatory standards. The ideal candidate will possess extensive knowledge in QMS, strong training skills, and experience in compliance monitoring.

Qualifications

• Experience in implementing QMS in a pharmaceutical or related industry.
• Familiarity with regulatory practices and standards.
• Strong analytical skills to monitor compliance and develop KPIs.

Responsibilities

• Support implementation and monitoring of Group Quality Management System.
• Develop policies, procedures, and training for affiliates.
• Manage Group Audit Program and Affiliate compliance.

Skills

Knowledge of Quality Management Systems

Regulatory Compliance

Training Development

GMP Knowledge

Education

Degree in Pharmacy or related field

Job description

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