Blackfield Associates
Quality System Specialist
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Quality Systems Officer – Pharmaceutical Grade
Blackfield Associates are supporting a leading pharmaceutical organisation in the search for a Quality Systems Officer based in Slough, with the role offering a broad development pathway within Quality Assurance.
This position will support the effective operation and continuous improvement of the Quality Management System, working closely with the Head of Quality and Qualified Person. The role offers hands-on exposure across:
- Deviations
- CAPAs
- Documentation control
- Batch review
- Audits
- Inspections
- Quality reporting
This makes it an ideal career development opportunity for someone interested in pharmaceutical quality.
Key Responsibilities
The role includes, but is not limited to:
- Supporting the maintenance and continuous improvement of the Quality Management System, covering:
- Deviations
- Change controls
- CAPAs
- Complaints
- Recalls
- Assisting with batch review activities, including:
- Checking manufacturing, packaging, and testing documentation for completeness
- Supporting compliance checks
- Drafting, reviewing, and updating:
- SOPs
- Policies
- Quality documentation
- Maintaining accurate document control
- Participating in:
- Internal audits
- Self-inspections
- Supporting preparation for external audits and regulatory inspections
- Supporting investigations into:
- Deviations
- Non-conformances
- Complaints (including root cause analysis and CAPA follow-up)
- Collating quality data, assisting with:
- KPI tracking
- Quality reports
- Contributing to Annual Product Quality Reviews
- Supporting:
- Training
- Continuous improvement initiatives
- Supplier quality activities
- Mock recalls
- Cross-functional quality projects
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Candidate Requirements
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The ideal candidate will have:
- Experience or strong grounding in GMP within a pharmaceutical or related environment
- A good understanding of Quality Management Systems
- Ideal exposure to an electronic QMS
- Strong written and verbal communication skills
- Excellent attention to detail
- Sound organisational ability
- The confidence to:
- Work independently
- Collaborate across functions
- A proactive, resilient, and results-driven mindset
- Analytical skills to:
- Manage multiple priorities
- Support investigations
- Challenge existing processes constructively
- Contribute to ongoing quality and compliance improvements
- Proficiency in Microsoft Office
- A genuine enthusiasm for the pharmaceutical industry with a strong interest in Quality Assurance
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