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QA Specialist

1 month ago

Sligo, Sligo, Ireland Cpl Full time

Our client, an expanding site in the biotech space are currently recruiting for a  Quality Assurance Specialist .

Sligo – Permanent - Onsite initially with option of some wfh as project requires.

They are seeking applicants that have 3-5 years experience with a degree in biopharmaceuticals or biomedical and have

a working knowledge of quality mgt systems, deviations, vendor mgt, change controls, CAPA's and batch record release.

This is a permanent role and has excellent opportunities forgrowth.

RESPONSIBILITIES:

·Site QA point of contact providing

technicalexpertise,feedback and guidance for QA and

compliance topics /issues including new product introduction and manufacturing

and assist inthe resolution of issues commensurate with the level of risk

·Manage assigned areas of Quality Management System(QMS) to ensure the manufacture of product in accordance with GMP andregulatory requirements.

·QMS areas of responsibility include Deviation,Change Control and CAPA management systems; Internal/External audits; Customer Complaints; Vendor Management; review/approval Manufacturing Batch Records and assessment/approval of production materials.

·Generate, review, and approve SOP's/otherdocumentation as applicable to your areas of responsibility.

·Perform timely review and approval of siteprocedures and documentation to ensure compliance with GMP and regulatory requirements.

·Review and approval of validation protocols/ reportsand related documentation to ensure compliance with current EU regulatoryexpectations and site procedures.

·Ensure schedules for review and approval of GMP/validation documents are maintained to support technology transfers and new product introduction project timelines.

·Ensure application of Quality Risk Managementprinciples as applicable

·Act as the QA lead in QA activities in projectwork-streams involving cross-functional, multidepartment teams includingOperations, Quality Control, Quality Assurance,

Engineering, and others.

·Actively contribute to continuous improvementactivities.

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