QA Specialist

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 levelsCarbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy