Senior Quality Assurance Officer
Location: Watford
Salary: £40,000-£45,000
Reporting To: Head of QA / Responsible Person
Job Overview
We are seeking an experienced and proactive Senior Quality Assurance Officer to support the Head of QA and Responsible Persons with all Quality and Regulatory activities across the business.
The successful candidate will play a key role in maintaining and continuously improving the Quality Management System (QMS), ensuring compliance with GDP/GMP requirements, and supporting regulatory obligations in line with MHRA, Home Office, and EU regulations.
This role requires a strong understanding of pharmaceutical quality systems, supplier oversight, deviations, CAPAs, audits, and GDP operations. The Senior QA Officer will work closely with operational departments to ensure all activities relating to the procurement, storage, distribution, export, and handling of pharmaceutical products are conducted in accordance with regulatory requirements and company procedures.
The ideal candidate will possess excellent communication skills, strong attention to detail, and the ability to manage multiple quality activities within a fast-paced pharmaceutical environment.
Key Responsibilities
Quality & GDP Compliance
Support the Responsible Person in maintaining GDP compliance and WDA obligations
Ensure continuous monitoring and improvement of the Quality Management System (QMS)
Ensure compliance with MHRA, Home Office, GDP, GMP, and EU regulatory requirements
Provide QA support across all departments to ensure regulatory compliance is maintained
Support recall management, incident handling, and escalation processes
Quality Systems & Documentation
Prepare, review, update, issue, and control SOPs and quality documentation
Review SOPs related to GDP/GMP activities and provide support to the Head of QA/RPs
Maintain quality department logs, trackers, and controlled documentation systems
Ensure effective filing and archiving of all quality-related records, both electronically and hard copy
Act as scribe during Quality Review meetings and support quality reporting activities
Deviations, CAPAs & Risk Management
Manage and investigate deviations, CAPAs, complaints, and temperature excursions within agreed timelines via eQMS
Initiate and support change control activities and associated risk assessments
Conduct risk assessments in line with ICH Q9 principles
Identify potential impacts of proposed changes and support implementation activities
Supplier & Customer Qualification
Manage supplier and customer qualification activities, including due diligence and QTA review
Verify UK, EEA, and non-EU pharmaceutical suppliers and customers
Conduct licence verification and compliance checks on suppliers and customers
Draft, review, and maintain Quality Technical Agreements with subcontractors and third parties
Audits & Inspections
Support MHRA inspections and regulatory audits
Conduct internal and external audits of vendors and suppliers
Provide QA oversight of warehouse operations including goods-in, quarantine, storage, distribution, and destruction activities
Training & Continuous Improvement
Support GDP training activities and maintain training records
Develop GDP training tools and materials where required
Monitor staff training compliance across departments
Support continuous improvement initiatives within the Quality function
Monitor and report quality KPIs and support management review processes
Attend training sessions and meetings as required by management
Qualifications & Experience
Degree in Life Sciences or related scientific discipline
Strong understanding of GDP/GMP regulations, ICH guidelines, ISO 9001, and EU pharmaceutical regulations
Experience working within a pharmaceutical QA environment
Knowledge of pharmaceutical storage and distribution requirements under GDP
Exposure to MHRA inspections and regulatory audits
Experience managing deviations, CAPAs, change controls, supplier qualification, and quality documentation
Experience within pharmaceutical wholesale, distribution, manufacturing, or import/export operations preferred
Skills & Competencies
Strong written and verbal communication skills
Excellent attention to detail and organisational skills
Ability to multitask and prioritise workload effectively
Strong decision-making and problem-solving abilities
Confident working independently and collaboratively within cross-functional teams
Proficient in Microsoft Office including Word, Excel, and Outlook
Professional, proactive, and quality-focused approach
What is on offer
Opportunity to work within a growing pharmaceutical organisation
Exposure to regulatory, GDP, and quality operations
Collaborative and supportive working environment
Ongoing professional development and training opportunities
Career progression within Quality and Regulatory Affairs