QA Specialist

4 weeks ago


Dublin, Ireland Cpl Full time

Position Summary

We are seeking to recruit a contract Senior Specialist, QA Compliance. Reporting to the Senior Manager, QA Compliance, the Senior Specialist, QA Compliance will support supplier quality operations.


Key Responsibilities

⢠Release incoming materials for use in manufacturing operations

⢠Support qualification of new suppliers/materials and requalification of existing.

⢠Assess supplier change notifications for impact to qualification status.

⢠Support material certification and direct dispense programs.

⢠Review and approve quality agreements.

⢠Authoring, review and approval of QA-related procedures.

⢠QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:

o Change controls

o Deviations/Investigations

o CAPAs

o Other associated documentation

⢠Support OpEx programs and champion continuous quality improvement initiatives.



Qualifications & Experience

BSc in Science or related discipline with a minimum of 2 yearsâ Supplier Quality or related experience in a Biologics or Pharmaceutical environment.

A clear understanding of cGMP requirements for QA systems and compliance and/or manufacturing.

Detailed knowledge of Biologics Processing would be a distinct advantage.

Required to work on his/her own initiative in addition to working as part of a team. Excellent communication, presentation, time-management and organizational skills are essential.



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