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:
- Perform batch reviews within required timelines
- Author and review SOPs
- Document and report all work in adherence with GMP and departmental procedures
- Review change controls and provide feedback / corrections to authors and escalate concerns to the Quality Manager/Head of Quality where necessary
- Raise, approve and review CAPAs
- Represent the QA team for improvement projects and with clients and internal teams
- Assist in the performance of supplier audits, supporting the Lead Auditor
- 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
- Conducts self-inspections / audits to ensure compliance with Quality Management System procedures and GMP regulations
- Ensuring that a timely and effective communication and escalation of quality issues to the appropriate levels of management
- Carries out site internal audits and identifies areas of GMP improvement during their daily duties
- Carries out training for QMS activities as defined by line management
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 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