Great opportunity for a Validation Doc Specialist to join our team with our medical device client in Limerick to support the document preparation. The role requires collaboration with Quality Engineering to ensure Validation/Quality Policies and Procedures are maintained
Your responsibilities will include
o Perform technical writing activities and assist the project engineers in the generation of all validation documentations including URS’s, FAT’s, SAT’s, test plans, deviations and discrepancies.
o Update and edit Operations Procedures and Work Instructions, project manuals, project presentations and reports,.
o To provide assistance with Change Control process to ensure that change implementation activities and deliverables are coordinated effectively in order to meet both the TRB and CCB requirements and timelines.
o Help coordinate FMEA sessions with Engineering as needed.
o Assist with attachment and upload of deliverables associated with change control.
o Help with non-critical Validation execution under direction of Engineering.
o Assist with purchasing and spare parts ordering
Your expeirence and education will include:
o Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base
o Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
o Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
For full details of this role please contact Ruth on 021 4777329 or apply directly through this advert.