Group Quality and Compliance Associate

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

Qualifications and Experience:

• Bachelor's or Postgraduate degree in Quality Management, Chemistry, Pharmacy, or equivalent degree (Science degree).
• GMP or ISO 9001 certification will be advantageous
• A minimum of 3 years of pharmaceutical industry experience within Quality Assurance
• Proven track record providing support in a similar function.
• Pharmaceutical industry experience (preferably within an international context)
• Demonstrated experience and understanding of GMP requirements.
• Implementation of Quality Management System (QMS)
• Ability to effectively communicate with various levels of business stakeholders, i.e., SMEs, Quality Managers, and technical representatives.
• Experience in document management.
• Experience in working within Digital Quality Systems.

Skills and Attributes:

• Ability to work in a multicultural, international, and dynamic environment.
• Global Thinking
• Risk management.
• Ability to work autonomously.
• Stakeholder management
• Strong Written Communication Skills
• Risk management.
• Teamwork & Cooperation
• Presentation skills
• Knowledge and application of Good Manufacturing Practices (GMP)
• Document management and quality systems (e.g. Veeva, TrackWise)
• Intermediate to Advanced Microsoft Office proficiency (Excel, Word, and PowerPoint)
• Auditing experience is advantageous.

Aspen Competencies:
Business:

• Foster Consumer and Customer Commitment
• Performance Driven
• Accountability/ Ownership

People:

• Communicate Effectively
• Lead and Influence Others

Self:

• Continuously Grow and Develop
• Contribute Special Expertise

Aspen is committed to the principles of equal employment opportunity. Preference will be given to applicants from designated groups through a fair recruitment and selection process in line with Aspen's Transformation Agenda.

Internal Applicants must inform their direct line managers of their application. Applications must be completed using an Aspen email address.

If you have not heard from the HC department within 30 days of this advert closing, please consider your application unsuccessful.