QA Senior Specialist Compliance

6 days ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

Overview

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

- 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.
- 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

- 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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