LSC have an immediate requirement for a QA Validation Specialist to qualify equipment at our start up biotech client based in Limerick.
Your responsibilities would include:
-Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval.
-Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ for cold temperature units; fridge, freezers, incubators, warehouses.
-Execute IQ, OQ and where necessary PQ protocols and drive post-approval of same.
-Interface with Commissioning and Process Sciences teams.
-Support CIP and SIP validation programs as necessary.
-Support Management in Project delivery.
The QA Validation Specialist will have:
-Third level qualification in Science or Engineering
-5 + years’ experience in GMP QA review preferably in Biotech
-Experience qualifying fridges/freezers/incubators/cold store rooms
-Experience in temperature mapping
– Experience in Document Preparation and Execution
-Experience in major start-ups where construction, C&Q, PQ may be concurrent activities.
-Good technical knowledge of Biotech equipment and the concepts of Biotech manufacturing.
-Have Troubleshooting and analytical mind-set
Call Kathy at LSC on 021 4777329 for more information on this QA Validation Specialist role or apply directly via this advert.