Quality Assurance Officer - Validation

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Quotient Sciences

Ensure that Quotient Sciences remains current and compliant with regulatory expectations on equipment and computerised system validation.
Support Alnwick Operations teams to ensure validation projects are completed in line with Quotient procedures and regulatory requirements.
To comply & adhere to GXP guidelines and regulations as required of this role.
Ensure that validation procedures are harmonised with global Quotient requirements.
Responsible for ensuring compliance through the Quality framework and follow procedures that govern the work performed in this role.

Authoring, reviewing and approving facilities, utilities, equipment, computerized system, and spreadsheet validation documents.
Authoring, reviewing, and approving incidents reporting as part of a validation project.
Providing technical validation support to operational colleagues.
Supporting ongoing change management of validated systems.
Supporting the maintenance of the site Validation Master Plan.
Maintenance of validation documentation (paper-based and electronic).
Conducting periodic reviews of validated systems
Maintain up to date knowledge of regulations & industry best practice relating to validation.
Assist with internal & customer audits and regulatory inspections where required.
Perform other duties as reasonably assigned.

A Life Science degree and a minimum of 2 years validation experience relating to facilities, utilities, equipment & computerised systems within a GxP environment (Good Laboratory Practice (GLP), Good Clinical Practice (GCP) or Good Manufacturing Practice (GMP).
Relevant quality assurance or IT experience will also be considered.
Excellent communication skills including the ability to effectively communicate across organisational levels and functions.
Competent in the use of Microsoft Office packages including Word, Excel, etc.

Don't forget to mention EuroPharmaJobs when applying.

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