SRG are working with a global name in the pharmaceutical industry to help them find a QA Specialist to join their team.
If you have Quality Assurance (QA) experience from a GMP environment then this could be a great next step for you.
The company offer an excellent benefits package and scope for growth and development.
The Role:
1. Perform batch reviews within required timelines
2. Author and review SOPs
3. Document and report all work in adherence with GMP and departmental procedures
4. Review change controls and provide feedback / corrections to authors and escalate concerns to the Quality Manager/Head of Quality where necessary
5. Raise, approve and review CAPAs
6. Represent the QA team for improvement projects and with clients and internal teams
7. Assist in the performance of supplier audits, supporting the Lead Auditor
8. Acts as a support to client and regulatory audits, helping with technical support to the audit team and responding to requests for documentation and information
9. Conducts self-inspections / audits to ensure compliance with Quality Management System procedures and GMP regulations
10. Ensuring that a timely and effective communication and escalation of quality issues to the appropriate levels of management
11. Carries out site internal audits and identifies areas of GMP improvement during their daily duties
12. Carries out training for QMS activities as defined by line management
Requirements:
13. Degree in a relevant scientific, engineering or business discipline and/or relevant industry experience
14. Several years' experience within Quality Assurance working to GMP guidelines
15. Experience of working within a Quality Management System e.g. completing or reviewing QMS documentation (SOPs/Deviations /Investigations /CAPA)
16. Experience of preparing and assisting in external audits with regulatory bodies such as FDA and MHRA
17. Organised and attention to detail
18. Strong communication skills across all levels