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.
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