Quality Coordinator

What can we offer you?Apart from job satisfaction, we can offer you:YOURSELF25 days’ holiday (with the option to buy more)HEALTHPrivate HealthcareOptional dental insurance, health assessments and health cash plansCycle to Work schemeWEALTHCompany Pension Scheme, matching contributions up to 5% of salaryLife assuranceAnnual staff bonus schemeSeason ticket loansAs 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 ResponsibilitiesQMSSupport 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 managementPerform 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 managementApproval 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 managementDocument 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 escalate 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-inspectionsProvide QA support during regulatory inspections and client audits.Complete internal audits and self-inspections.Tracking completion of GMP self-inspections and aud...