Quality Coordinator

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 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-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 envi

Benefits

Additional Information

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. the Hammersmith (UK) site, 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.

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