LSC have a great contract opportunity for Quality Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
If you have 5+ years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment
and ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Responsible for QA oversight of cold chain activities in all markets in accordance with local and international requirements and Alexion 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 Alexion'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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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. Engineering, or equivalent.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Pawel Jurkiewicz at LSC on 021-4777329 if you have any more questions about this role!