QA Specialist

7 days ago

Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time
QA Specialist - Dublin, Ireland - 12 Months Contract

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

An exciting project with 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:
  1. Release incoming materials for use in manufacturing operations
  2. Support qualification of new suppliers/materials and re-qualification of existing.
  3. Assess supplier change notifications for impact to qualification status.
  4. Support material certification and direct dispense programs.
  5. Review and approve quality agreements.
  6. Authoring, review and approval of QA-related procedures.
  7. QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:
  • Change controls
  • Deviations/Investigations
  • CAPAs
  • Other associated documentation
Support OpEx programs and champion continuous quality improvement initiatives.Key requirements include:
  1. BSc in Science or related discipline with Supplier Quality or related experience in a Biologics or Pharmaceutical environment.
  2. A clear understanding of cGMP requirements for QA systems and compliance and/or manufacturing.
  3. Detailed knowledge of Biologics Processing would be a distinct advantage.
  4. 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.
  5. Employees are expected to display Biopharma Behaviours, which enable them to be successful and perform at their highest level.

If this role is of interest, please apply now

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