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QA Compliance Specialist

  • Location:

    Dublin

  • Sector:

    Pharmaceutical Industry

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Next Generation

  • Contact email:

    raquel.lourenco@nextgeneration.ie

  • Job ref:

    JOB-13737_1707309452

  • Published:

    17 days ago

Reporting to the Senior Manager, QA Compliance, the Senior Specialist, QA Compliance will support supplier quality operations

This is a contract position until 31 Dec 2024.

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 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 organizational skills are essential