Quality Coordinator

As Quality Coordinator, you will provide GxP Quality Assurance oversight at our state‑of‑the‑art radiopharmaceutical production and clinical trial imaging facility located in Hammersmith, West London. Working under the direction of the GMP Quality Manager, you will support compliance with company and regulatory GxP requirements by overseeing quality processes, including deviation management, vendor management, change control, internal audits and self‑inspections.

Benefits

• 25 days holiday (with an option to purchase additional days)
• Private healthcare, with optional dental insurance, health assessments and health cash plans
• Cycle to Work scheme
• Company pension scheme, matching contributions up to 5% of salary
• Life assurance
• Annual staff bonus scheme
• Season ticket loans

Quality Management System

• Support the use and administration of the QMS and ensure delivery of commitments to clients and sponsors per established Quality Agreements.
• Participate in regulatory assessment as required.

Deviation Management

• Perform quality oversight of the deviation management system, ensuring investigations are thorough and root causes are identified.
• Critically review CAPA to ensure they are fit for purpose and have a line of sight to the original event.
• Coordinate, track, review and support approval of deviation investigations in line with QMS requirements.

Document Management

• Approve and issue batch records and other GxP documents as required.
• Coordinate issuance and tracking of controlled documents, ensuring GMP standards are maintained.
• Collate completed GMP documentation and coordinate associated archiving activities.

Vendor Management

• Conduct risk assessments of vendor quality systems via on‑site audits, questionnaires or other tools.
• Ensure designated vendors are audited regularly to meet regulatory and quality standards; elevate vendor quality issues and risks to management.
• Coordinate vendor qualification and audit schedules, arrange and perform supplier and vendor audits.
• Provide vendor‑management expertise during client audits.

Internal Auditing and Self‑Inspections

• Provide QA support during regulatory inspections and client audits.
• Complete internal audits and self‑inspections; track completion and actions arising from inspections.

Training

• Deliver GxP training to employees and contractors.

Batch Release and Record Review

• Perform QA release of product and approve batch records in accordance with GMP.

Continuous Improvement

• Identify opportunities for quality‑management improvement and implement initiatives to improve compliance and business efficiency.

Quality Risk Management

• Act as quality oversight for risk identification and assessment processes.

Functional Competencies

• Strong motivation and commitment to continuous learning.
• Intermediate proficiency in Microsoft Office, Excel and Adobe PDF.
• Culturally aware with strong interpersonal, verbal and written communication skills.
• Good understanding of GMP within the pharmaceutical industry and applicable regulatory standards.
• Advanced knowledge of QMS elements and continuous‑improvement methodologies.
• Sense of urgency and timely completion of commitments.
• Effective communication of quality issues and recommendations to functional groups.
• Professional handling of confidential information with discretion.
• Capacity to train and support less‑experienced Quality team members.
• Independent and reliable work in a fast‑paced environment.

Experience, Education and Certifications

• Essential experience in a Good Manufacturing Practice (GMP) environment (manufacturing or research).
• Knowledge of sterile manufacturing is preferred.
• Experience in QC or QA within a pharmaceutical environment is essential; experience with radiopharmaceuticals is ideal.
• Understanding of advising manufacturing or project teams from a quality and GxP compliance perspective.
• Understanding of QMS maintenance, risk management, auditing and/or computerized systems.
• Study to degree level (Chemistry or Life Sciences preferred) or equivalent qualification.
• Fluent in English.

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