LSC work exclusively in the Life Science sector; founded and run by contractors we understand contracting first hand and have created a unique solution to make the process as easy as possible - so you can focus on getting your work done!
At LSC we partner with you for the long term, not just your contract duration. We are committed to building relationships and will work with you to ensure you are placed on projects that challenge and reward you throughout your career.
A QA Validation Specialist is required by 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 Validation Specialist will be responsible for:
o Providing quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition.
o Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert.
o Review and approval equipment/utilities verification documentation from design to post execution.
o Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
o QA support for implementation of Manufacturing Execution System (MES) computer system validation deliverables.
o Review and approval of engineering functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
o Authoring, review and approval of QA-related procedures.
The QA Validation Specialist will require:
o B.Sc. in science/pharmacy with a minimum of 5 years' experience in cGMP Quality environment to include biopharmaceutical experience.
o Min 5 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment. (BDS experience is essential).
o Must have strong process knowledge to include upstream and/or downstream processing.
If you would like to hear more about this QA Validation Specialist role, then please contact Kathy at LSC on 021-4777329 or apply direcltly through this advert.