LSC have a great contract opportunity for a QA Operations Specialist – NPI 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.
The QA Operations Specialist – NPI will be responsible for:
o Provide quality and cGMP input and oversight focused on the transfer of new products to the site – through commercial readiness and ongoing product manufacturing and disposition for biologics facility.
o Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert.
o Support the introduction of all associated new materials, including qualification of the materials and associated vendors.
o Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained / controlled.
o Review and approval of technical support documentation. (Examples include associated technical transfer documentation, process, method validation)
o Review and approval of manufacturing batch records.
The QA Operations Specialist – NPI will require:
o B.Sc. in science/pharmacy/engineeringwith a minimum of 3 years’ experience in cGMP Quality environment
o Experienced QA professional with QA Operations experience
o 3-5 years’ experience in QA positions preferably pharmaceutical and/or biotech products
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!
If you would like to hear more about this QA Operations Specialist – NPI role, then please contact Ciaran at LSC on 021-4777329 or apply directly through this advert.