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
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