Quality Coordinator

Perceptive Group; Greater London; Hybrid; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Private Healthcare

Dental insurance

Health assessments

Health cash plans

Cycle to Work scheme

Company Pension (5% matching)

Life assurance

Annual bonus scheme

Season ticket loans

Job summary

Perceptive is seeking a Quality Coordinator to provide GxP QA oversight at a radiopharmaceutical production and imaging facility in Hammersmith, West London. You will work under the GMP Quality Manager to ensure compliance with GxP, manage deviations, audits, and QMS processes.

You will collaborate across teams to drive continuous process improvements, maintain QA documentation, and support regulatory inspections and client audits.

Qualifications

• Experience in GMP environment is essential.
• Knowledge of sterile manufacturing is preferred.
• Experience in radiopharmaceuticals is ideal.
• Bachelor-level degree in Chemistry or Life Sciences or equivalent.
• English: Fluent.

Responsibilities

• Provide QA oversight of QMS and GMP/GLP guidelines.
• Coordinate deviations, CAPAs, and change controls.
• Manage audits, self-inspections, and vendor assessments.
• Support regulatory inspections and client audits.
• Coordinate document control and batch record review.
• Deliver QA training and continuous improvement initiatives.

Skills

Continuous learning

Microsoft Office

Excel

Adobe PDF

Effective communication

QA mindset

Education

Degree in Chemistry or Life Sciences

English Fluent

Tools

GxP knowledge

QMS knowledge

Job description

What can we offer you?

Apart from job satisfaction, we can offer you:

• YOURSELF 25 days’ holiday (with the option to buy more)
• HEALTH Private Healthcare
• Optional dental insurance, health assessments and health cash plans
• Cycle to Work scheme
• WEALTH Company Pension Scheme, matching contributions up to 5% of salary
• Life assurance
• Annual staff bonus scheme
• Season ticket loans

As Quality Coordinator, you'll be responsible for providing GxP Quality Assurance oversight at our state‑of‑the-art radiopharmaceutical production and clinical trial imaging facility in Hammersmith, West London. Under the direction of the GMP Quality Manager, you'll support compliance with company and regulatory GxP requirements by overseeing quality processes, including deviation management, vendor management, change control, internal audits and self‑inspections. As part of a small supportive team, you'll administer and maintain the Quality Management System (QMS) in accordance with company procedures and applicable GxP standards and guidelines and deliver GxP Quality training to employees and contractors. Working collaboratively with stakeholders and team members, you'll also contribute to the identification and implementation of continuous process improvement initiatives across all business units.

Key Responsibilities

• QMS Support the use and administration of the Quality Management System (QMS)
• Ensure the delivery of commitments to clients and sponsors in accordance with established Quality Agreements.
• Participate in regulatory assessment as required.
• Deviation management Perform quality oversight of the deviation management system, ensuring investigations are thorough and appropriately identify root cause/s.
• Provide critical review of CAPA to ensure they are fit for purpose, and that they have line of sight to the original event.
• Coordinate, track, review and support the approval of deviation investigations, out of specifications with QMS requirements.
• Document management Approval and issuance of batch records and other GxP documents as required.
• Coordinate issuance and tracking of controlled documents.
• Issue of batch documents and collation and review of records post manufacture to ensure appropriate GMP standards are maintained.
• Collation of completed GMP documentation and coordination of associated archiving activities.
• Vendor management Document risk assessments of vendors quality systems by means of on‑site audits, questionnaires or other tools.
• Ensure designated vendors are audited on a regular basis to ensure regulatory and quality standards are met and escape vendor quality issues and risks to management.
• Coordinate vendor qualification and audit schedules.
• Arrange and perform audits of suppliers and vendors.
• Provide subject matter expertise on vendor management practices during client audits.
• Internal auditing and self‑inspections Provide QA support during regulatory inspections and client audits.
• Complete internal audits and self‑inspections.
• Tracking completion of GMP self‑inspections and audits.
• Track actions arising from Inspections, audits, and self‑inspections.
• Support Local Quality Compliance Council Generate quality metrics and trend data to support the on‑going management of compliance through the Quality Council.
• Training Perform training relating to the quality systems and GxP.
• Batch release and batch record review Perform QA release of product.
• GMP review and approval of batch records and other completed GMP records Continuous improvement Identify opportunities to quality management for improving processes to benefit quality, compliance, business efficiency.
• Implement initiatives to benefit quality, compliance, business efficiency.
• Quality Risk Management Act as quality oversight for risk identification and assessment processes.

Functional Competencies (Technical knowledge/Skills)

• Highly motivated with a strong commitment to continuous learning and professional development
• Demonstrates intermediate proficiency in desktop software applications, including Microsoft Office, Excel and Adobe PDF
• Culturally aware, with the ability to think and work effectively in a global environment, supported by strong interpersonal, verbal and written communication skills
• Good understanding of Good Manufacturing Practice (GMP) within the pharmaceutical industry, with demonstrated ability to apply regulatory standards and guidelines
• Advanced knowledge of elements of the Quality Management System and continuous improvement methodologies
• Demonstrates a strong sense of urgency when addressing issues and ensures timely completion of commitments
• Effectively communicates quality issue, along with potential recommendations, to various functional groups.
• Handles highly confidential information with professionalism and discretion
• Capable of training and supporting new and less experienced Quality team members
• Able to work independently and reliably in a fast‑paced environment

Experience, Education and Certifications

• Experience working in a Good Manufacturing Practice (GMP) environment - either manufacturing or research - essential.
• Knowledge of steriles manufacturing preferred.
• Exposure to working in operations, QC or QA within a pharmaceutical environment essential - experience working in radiopharmaceuticals would be ideal.
• Good understanding of advising manufacturing or project teams from a quality and GxP compliance perspective.
• Good understanding of QMS maintenance, risk management, auditing and/or computerized systems.
• Educated to degree level (Chemistry or Life Sciences preferred) or equivalent qualification.
• English: Fluent

At Perceptive, we enable the world’s pharmaceutical, biotech, and clinical research organizations to rapidly discover and advance life‑changing treatments. Together, our global team delivers unmatched scientific and technological expertise, global operational experience, and end‑to‑end solutions to help the global research community realize tomorrow’s new therapies. To do this, we need people like you. At Perceptive, your work will enable our customers to bring lifesaving and life‑improving options to patients around the world. Learn how you can make a difference by joining our team and uniting under our shared goal – serving science to improve people’s lives.