QA Specialist- Supplier Assurance

SRG are working with a global name in the pharmaceutical industry to help them find a Supply Chain QA Specialist to join their team.

If you have Quality Assurance (QA) and auditing experience or an auditing qualification then this could be the perfect next role for you.

The company offer an excellent benefits package and scope for growth and development.

The Role:

• Maintain, and monitor a complex network of suppliers supporting GMP manufacture including:
• Active risk management.
• On-site supplier audits for critical suppliers, including analytical testing labs, warehousing, materials manufacture, sterilisation sites and more.
• High-quality report writing for supplier risk assessments and audits delivered in a timely manner.
• Maintain data driven risk matrices, both locally and globally.
• Maintain an Approved Supplier List for the site, including all materials and services used across a range of applications with appropriate risk mitigation for each.
• Implement and maintain, where assessed as necessary, supplier Quality Technical Agreements and Non-disclosure agreements.
• Maintain strong, effective working relationships with clients, domestically and internationally.
• Maintain physical and digital records supporting supply chain compliance, and ensure coherence and accuracy of all records.
• Plan, execute and review the supplier qualification program independently, including liaising with internal and external stakeholders, planning audit agendas, writing comprehensive audit reports, and monitoring and closing out post-audit activities where necessary.
• Undertake a critical review of third-party audit reports, and assess associated documentation in a risk proportionate manner.
• Liaise, and closely integrate with, a global team of auditors and managers to ensure compliance with a Globally administered supplier management system, providing ongoing support for other networked sites.
• Escalate, where necessary, perceived supply chain risks, and implement mitigating actions to reduce supply chain risk.
• Work closely with project leads, warehousing and procurement staff to ensure timely and compliant supply of appropriate materials to support GMP manufacture and release.
• Manage vendor complaints and change notifications as part of an ongoing supplier risk management programme.
• Support internal audits, and provide ongoing training and support for other internal auditors on site.
• Actively manage the training of audit qualified staff to maintain a strong bench of SMEs capable of supporting or executing the audit program.

Requirements:

• Degree in a relevant scientific, engineering or business discipline and/or relevant industry experience
• Several years’ experience within Quality Assurance working to GMP guidelines
• Experience of auditing, supplier assurance and/or auditing qualification is essential
• Experience of working within a Quality Management System e.g. completing or reviewing QMS documentation (SOPs/Deviations /Investigations /CAPA)
• Experience of preparing and assisting in external audits with regulatory bodies such as FDA and MHRA
• Organised and attention to detail
• Strong communication skills across all levels