LSC have a great contract opportunity for a QA Distribution Specialist to join a biopharmaceutical company based in Dublin. The company is focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
If you have 3+ years QA experience in a HPRA/FDA/EU & GDP regulated environment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o 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.
o Ensuring QA distribution batch release of shipments at the 3PL Distribution centers.
o Assess cold chain shipments and provides corresponding quality decision on product.
o Review documentation including change controls, deviations, validation documentation, SOPs and specifications.
o Ensure Quality Agreement with distribution contractors and carriers are established and maintained.
o Assess and process product returns in conjunction with the Logistics team.
o Provide Quality and compliance support to projects impacting College Park Distribution site activities.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering
o Knowledge of Cold Chain activities
o Knowledge of GDP and global regulatory requirements
o Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements
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!
To apply, submit your CV via this advert or contact Siobhan Cummins at LSC on 021-4777329 if you have anymore questions about this QA Distribution Specialist opportunity!