Are you an experienced QA professional looking to broaden your expertise? Join a growing pharmaceutical business where you'll gain exposure to Quality Assurance, Regulatory Affairs and CMO collaboration while supporting a diverse and expanding product portfolio.
The Role
Reporting to the Quality & Regulatory Manager, you'll play a key role in maintaining the Quality Management System, ensuring regulatory compliance, supporting product release, and driving continuous improvement across quality and regulatory activities.
Key Responsibilities
- Manage and maintain Quality Systems, including deviations, CAPAs, change control, complaints, document control and non-conformance investigations.
- Support the timely review and release of finished products while ensuring compliance with cGMP and regulatory requirements.
- Coordinate regulatory submissions, product registrations and artwork/labelling updates to support compliant product launches.
- Develop and maintain SOPs, monitor quality KPIs and contribute to continuous improvement initiatives.
- Build strong relationships with internal stakeholders and Contract Manufacturing Organisations (CMOs) to ensure quality and regulatory compliance.
- Keep up to date with evolving regulatory requirements and promote a strong quality culture across the business.
About You
- BSc (or equivalent) in a scientific discipline.
- 5+ years' Quality Assurance experience within a GMP pharmaceutical manufacturing environment.
- Strong knowledge of Quality Systems, cGMP and regulatory compliance.
- Excellent communication, organisation and problem-solving skills.
- Experience in Regulatory Affairs, artwork review or Supplier Quality would be advantageous but is not essential.
Why Join?
- Hybrid working within a collaborative office environment.
- Growing team with an expanding product portfolio.
- Broaden your experience across QA, Regulatory Affairs, Artwork and CMO management.
