Full job descriptionQuality 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.