Quality Coordinator

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.

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.

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.

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.

Generate quality metrics and trend data to support the on-going management of compliance through the Quality Council.

Perform training relating to the quality systems and GxP.

Perform QA release of product.

GMP review and approval of batch records and other completed GMP records

Identify opportunities to quality management for improving processes to benefit quality, compliance, business efficiency.

Implement initiatives to benefit quality, compliance, business efficiency.

Act as quality oversight for risk identification and assessment processes.

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