Qa Senior Specialist Compliance

1 week ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

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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