LSC have an immediate requirement for QA Validation Specialist for our start up biotech client based in Limerick.
As QA Validation Specialist you will complete Document Preparation and Field Execution activities for the initial Qualification and Validation of theis biotech facility and will be working in the the areas of Clean Utilities, HVAC, Upstream, Downstream, CIP, SIP and QC Labs
Your responsibilties would include:
o Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval.
o Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ,
o Cleaning Validation protocols; drive approval of same.
o Execute IQ, OQ and where necessary PQ protocols and drive post-approval of same.
o Interface with Commissioning and Process Sciences teams.
o Support CIP and SIP validation programs as necessary.
o Support Management in Project delivery.
The QA Validation Specisliat will have: :
o Third level qualification in Science or Engineering
o 2 + years experience in GMP QA review preferably in Biotech
o xperience in Document Preparation and Execution
o Experience in major start-ups where construction, C&Q, PQ may be concurrent activities.
o Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing.
o Have Troubleshooting and analytical mindset
Call Kathy at LSC on 021 4777329 for more information on this new QA Reviewer role or apply directly via this advert.