LSC have a great contract opportunity for a Senior QA Specialist to join a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have relevant experience (5yrs +) 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, Quality Control, Supply Chain, Engineering, Information Systems) and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
o Quality review and approval of Process Development and Validation documentation
o Review of DS & QRAES documents
o Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
o Review of executed validation documents and reports
o Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet company and regulatory expectations.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o University degree. Science or Engineering related discipline preferred.
o Understanding of principles of Validation and New Product Introduction
o Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
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 Katie Brown at LSC on 021-4777329 if you have anymore questions about this Senior QA Specialist opportunity!