LSC have an immediate requirement for a QA Validation Specialist to qualify equipment at our start up biotech client based in Limerick.
As QA Validation Specialist you will complete document preparation and execution activities for the initial Qualification and Validation.
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.