Company

QualityCoordinator

United Kingdom FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Quality Coordinator. Skills: Quality Assurance, GxP Compliance, QMS Administration, Vendor Management. Provide GxP Quality Assurance oversight. Support compliance with GxP requirements”

What You'll Achieve.

Ensure the delivery of commitments to clients and sponsors; ensure investigations are thorough and appropriately identify root cause/s; ensure they are fit for purpose; ensure appropriate GMP standards are maintained; ensure regulatory and quality standards are met; benefit quality, compliance, business efficiency

What They're Looking For.

Must Have

Experience working in a Good Manufacturing Practice (GMP) environment - either manufacturing or research - essential, Exposure to working in operations, QC or QA within a pharmaceutical environment essential, 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

Nice to Have

Knowledge of steriles manufacturing preferred, experience working in radiopharmaceuticals would be ideal

What You'll Do.

Provide GxP Quality Assurance oversight

Support compliance with GxP requirements

Oversee quality processes

Administer and maintain Quality Management System (QMS)

Deliver GxP Quality training

Contribute to continuous process improvement

Perform quality oversight of deviation management

Provide critical review of CAPA

review deviation investigations

Approval and issuance of batch records

Coordinate issuance and tracking of controlled documents

Issue of batch documents

Collation of completed GMP documentation

Document risk assessments of vendors

Ensure vendors are audited regularly

Coordinate vendor qualification and audit schedules

Arrange and perform audits of suppliers

Provide QA support during inspections

Complete internal audits and self-inspections

Generate quality metrics and trend data

Perform training relating to quality systems

Perform QA release of product

GMP review and approval of batch records

Identify opportunities for improving processes

Implement initiatives to benefit quality

Act as quality oversight for risk identification

How You'll Work.

Team & Collaboration

Working collaboratively with stakeholders and team members; Effectively communicates quality issue, along with potential recommendations, to various functional groups; Capable of training and supporting new and less experienced Quality team members

Communication Scope

interpersonal; verbal; written communication skills

Full 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. 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. # **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

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