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QA Distribution Specialist

4 weeks ago

Dublin, Ireland TN Ireland Full time

QA Distribution Specialist - Life Science - Contract - Dublin

Are you looking for the chance to join a life-changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a QA Distribution Specialist to support the QA Distribution Specialist function.

Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation paves the way with state-of-the-art technology on their one-of-a-kind manufacturing facility.

QA Distribution Specialist Responsibilities:
  1. Responsible for Quality oversight of temperature controlled product activities in all markets in accordance with local and international requirements and planning schedules; ensure products shipments are managed in accordance with GDP’s requirements.
  2. Assess temperature controlled shipments and provide corresponding quality decision on product.
  3. Act as primary Quality technical contact point with distribution partners.
  4. Provide guidance, drive and monitor Quality issues related to temperature controlled products and GDP to resolution within the company and with external parties.
  5. Review documentation including change controls, deviations, validation documentation, SOPs and specifications.
  6. Ensure Quality Agreement with distribution contractors and carriers are established and maintained. Support the conduct of Quality and Operations review meeting with Distribution contractors.
About you:
  1. Minimum 5 years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment.
  2. Thorough knowledge of temperature controlled product activities.
  3. Thorough knowledge of cGMPs/GDPs and global regulatory requirements.

Are you a good fit for a QA Distribution Specialist? Get in touch with us today.

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