Quality Assurance Officer

Quality Assurance Specialist (Pharmaceutical / GMP) Location: Hertfordshire Job Type: Permanent | Full-time Competitive salary + benefits About the Company Our client is a well-established and growing organisation operating within a highly regulated pharmaceutical/manufacturing environment. With a strong commitment to quality, compliance, and continuous improvement, they are looking to strengthen their Quality function with the addition of an experienced Quality Assurance professional. The Role This is a fantastic opportunity for a detail-oriented QA professional to take ownership of core Quality Management System (QMS) activities and support regulatory compliance across the business. You will play a key role in maintaining quality standards across manufacturing, documentation control, supplier management, and regulatory processes. Key Responsibilities Quality Management System (QMS) • Maintain and improve the QMS in line with MHRA, GMP, and ISO requirements • Conduct internal audits and self-inspections, ensuring CAPAs are effectively implemented • Carry out quality walks and produce audit reports Documentation & Compliance • Manage controlled documentation, including SOPs, specifications, and batch records • Review and approve Master Batch Production Records (BPRs) and Batch Assembly Records (BARs) • Ensure documentation aligns with regulatory licences and standards Regulatory & Quality Oversight • Support regulatory submissions (including CTD modules) • Assist during external audits and regulatory inspections • Prepare Product Quality Reviews (PQRs) Quality Operations • Manage deviations, change controls, and CAPAs • Conduct investigations and generate reports • Perform risk assessments and gap analyses • Review BOMs and work orders within ERP systems (e.g. SAGE) Supplier Quality • Manage supplier quality documentation and agreements • Investigate supplier issues and maintain strong vendor relationships Reporting & Continuous Improvement • Track and report Quality KPIs • Provide insights to drive business improvement initiatives About You Qualifications & Experience • Degree in Pharmaceutical Sciences, Chemistry, Life Sciences, or similar • Proven experience in a GMP-regulated environment (pharmaceutical, medical device, or similar) • Strong knowledge of MHRA/FDA regulations, GMP, GDP, and ISO standards • Experience with QMS processes including deviations, CAPAs, and change control • Experience preparing for and supporting audits • Familiarity with ERP systems (e.g. SAGE) is desirable Skills • Exceptional attention to detail • Strong organisational and time-management skills • Effective communicator, able to work cross-functionally • Analytical mindset with strong problem-solving abilities • Ability to manage multiple priorities and meet deadlines What’s on Offer • Competitive salary package • Opportunity to join a growing, quality-focused organisation • Exposure to regulatory and compliance activities at a high level • Supportive and collaborative working environment Apply now or contact us confidentially to find out more.