LSC have a great contract opportunity for a QA Validation – Continuing Validation to join an innovative and rapidly growing Biopharmaceutical company in Limerick.
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Implements continuning qualification program for initial qualification of manufacturing equipment and or supporting utilities, at the Raheen, Limerick bulk biologics facility.
o This include document preparation for:
Equipment Qualification Assessments (EQAs)
Installation Qualifications (IQs), Operational Qualifications (OQs), and where applicable Performance Qualifications (PQs).
Summary Reports (SRs), Trace Matrices (TMs)
This includes execution for IQ, OQ and where applicable, PQ.
o Based on engineering specification, performs validation projects which include authoring protocols, executing validation protocols and writing reports of validation results.
o Reviews Validation protocols and summary reports generated by the Validation team against standard operating procedures and policies.
o Reviews Change Control test plans generated by the Engineering/Automation/Manufacturing teams against standard operating procedures and policies.
FIELD OF KNOWLEDGE/EXPERTISE:
o Experienced in System Validation activities
o Generation, review & approval of IOPQ protocols and associated validation documents and supervison on execution activities associated with large scale manufacturing equipment
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 Kathy Gillen at LSC on 021-4777329 if you have anymore questions about this QA Validation – Continuing Validation opportunity!