Senior QA Specialist

2022-05-13 11:54:362049-10-11Team Horizon
Job TypeContractor
LocationDublin
AreaDublinDublinIrelandDublin
SectorQuality
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref2469
Job Views239
Description
Senior QA Specialist – Team Horizon
We have an exciting opportunity available for a QA Technical Support (QA TS) Specialist (12-month Contract) with our client who are a global biopharmaceutical company. This is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
 
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.
  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  • Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
 
What you will be doing:
  • Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet Amgen and regulatory expectations.
  • Quality review and approval of Process Development and Validation documentation
  • Technical transfer documents
  • Validation Protocols, executed validation documents and reports
  • Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
  • Perform all activities in compliance with Amgen safety standards and SOPs
 
What you need to apply:
  • University degree in Science or Engineering related discipline preferred.
  • Understanding of principles of Validation and New Product Introduction
  • Experience in aseptic manufacturing
  • Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
  • Ability to operate across functional boundaries, both internal and external.
  • Ability to work independently and remotely with minimum direct supervision.
  • Critical thinking skills.
  • Strong organisational, communication, coordination, and meeting facilitation skills.
  • Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
  • Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
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Darcy Ainscough-Denton
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