Quality Assurance Specialist Full Time

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