Quality System Specialist

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 will provide hands-on exposure across deviations, CAPAs, documentation control, batch review, audits, inspections, and quality reporting, making it an excellent opportunity for someone looking to develop their career within pharmaceutical quality.

Key responsibilities within the position will include, but not be limited to:

• Supporting the maintenance and continuous improvement of the Quality Management System, including deviations, change controls, CAPAs, complaints and recalls.
• Assisting with batch review activities, including checking manufacturing, packaging and testing documentation for completeness and supporting compliance checks.
• Drafting, reviewing and updating SOPs, policies and quality documentation, while maintaining accurate document control.
• Participating in internal audits and self-inspections, and supporting preparation for external audits and regulatory inspections.
• Supporting investigations into deviations, non-conformances and complaints, including root cause analysis and CAPA follow-up.
• Collating quality data, assisting with KPI tracking and quality reports, and contributing to Annual Product Quality Reviews.
• Supporting training, continuous improvement initiatives, supplier quality activities, mock recalls and wider cross-functional quality projects.

The correct candidate for this opportunity will have experience or a strong grounding in GMP within a pharmaceutical or related environment, alongside a good understanding of Quality Management Systems and ideally exposure to an electronic QMS. You will bring strong written and verbal communication skills, excellent attention to detail, sound organisational ability, and the confidence to work both independently and collaboratively across functions. The successful candidate will have a proactive, resilient and results-driven mindset, with the analytical skills to manage multiple priorities, support investigations, challenge existing ways of working constructively and contribute to ongoing quality and compliance improvements. Proficiency in Microsoft Office is required, along with a genuine enthusiasm for the pharmaceutical industry and a strong interest in Quality assurance.