Quality Specialist

2022-08-04 10:17:292049-12-30Team Horizon
Job TypeContractor
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref2497
Job Views299
Quality Specialist – Team Horizon
We have an exciting opportunity for our client, who are a leading biopharmaceutical company based in Dublin.As the Quality Specialist, you will be responsible for the quality oversight of the distribution of the company’s products world-wide. The position ensures product shipments are managed in compliance with GDP requirements and applicable company procedures. You will support Logistics, Customer Operations and Commercial Distribution functions globally and is primary QA technical contact point with external distribution partners.  
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

What you will be doing:
Responsible for QA oversight of cold chain activities in all markets in accordance with local and international requirements and the client’s planning schedules; ensure products shipments are managed in accordance with GDP’s requirements.
Assess cold chain shipments and provides corresponding quality decision on product.
Act as primary QA technical contact point with distribution partners. Provide guidance, drive and monitor Quality issues related to cold chain and GDP to resolution within the company and with external parties.
Review documentation including change controls, deviations, validation documentation, SOPs and specifications.
Ensure Quality Agreement with the client’s distribution contractors and carriers are established and maintained. Support the conduct of Quality and Operations review meeting with Distribution contractors. 
Contribute to define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to GDP’s contractors.
Support the preparation of Health Authorities inspections and provide support for regulatory submissions.

What you need to apply:
  • 5+ years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment
  • Thorough knowledge of Cold Chain activities
  • Thorough knowledge of cGMPs/GDPs and global regulatory requirements
  • International exposure in positions interacting with and influencing site operations.
  • Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements.
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