Summary: SRG is seeking a Quality Assurance Specialist for a global pharmaceutical company. The ideal candidate will have experience in Quality Assurance within a GMP environment and will be responsible for performing batch reviews, authoring and reviewing SOPs, and conducting audits. The role offers opportunities for growth and development within the company. The responsibilities include documenting work in adherence to GMP, reviewing change controls, and representing the QA team in improvement projects. Candidates should possess a relevant degree and several years of QA experience, with strong communication skills and attention to detail.
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
