Qa Senior Specialist Compliance

QA Senior Specialist Compliance - Ireland, Dublin - 6 Months Contract

One of the top 10 best companies to work in Ireland is looking for a QA Senior Specialist Compliance for their large-scale new facility in Dublin.

Is this you?

An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project.

This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.

Responsibilities include :

Review and approve quality agreements.

Release incoming materials for use in manufacturing operations

Support qualification of new suppliers / materials and re-qualification 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.

Support OpEx programs and champion continuous quality improvement initiatives.

QA review, assessment and approval activities for Biologics Manufacture, as applicable, for : Change controls, Deviations / Investigations, CAPAs, Other associated documentation

Key requirements include :

BSc in Science or related discipline with a minimum of 2 years' 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 organisational skills are essential.

If this role is of interest, please apply now!

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