IS Lead AnalysT
|Job Title:||IS Lead AnalysT|
|Job Published:||over 1 year ago|
Our client, a medical device company in Cork are currently looking to recruit a IS Lead Analyst for their site.
This position works across the global IS organization to execute the IS Compliance and Audit Program managed by IS Regulatory Compliance. General responsibilities include performing audits, tracking action plans, and serving as the IS NC/CAPA Specialist.
Essential Duties & Responsibilities
? Prepare, plan, perform, report audits and track actions from the IS Compliance and Audit program.
? Open, track, approve and close NCs and CAPAs owned by IS as the NC Specialist / CAPA Specialist.
? Mentor IS NC and CAPA owners in the progression of their records.
? Facilitate the IS NC/CAPA Review Board, including agenda distribution, minutes and tracking.
? Lead or participate in preparation activities at the site level for audits (FDA, Notified Body, Corporate, etc.); Interface with RA QA groups and external audit teams as ISRC Lead by following the IS Audit Playbook.
? Foster an IS continuous improvement culture through the deployment of the ISRC Compliance Education program which may include presentations, position papers or guidance documents.
? Participate in the Major Incident Review process to ensure escalation to NCs where appropriate.
? Develop IS Compliance and Audit metrics and dashboards.
? Partner with ISRC and the broader IS Governance and Performance Management team members to ensure a consistency in quality assurance globally including but not limited to IS ISO QMS interpretation and process adherence.
? May participate in other ISRC processes and initiatives as required (e.g., CSV, Change Control reviews).
? May develop global procedures or internal ISRC procedures where appropriate.
? Recommend and implement process improvements as they relate to the IS ISO QMS and other ISRC processes.
Minimum Qualifications Bachelor?s Degree or equivalent required
? 5 years of work experience in Computer Systems Validation (CSV) would be preferred
? 5 years of work experience in an FDA-regulated environment
? 5 years of work experience in IS, Regulatory Compliance, or related QA role
? Excellent written and oral communication skills
? Working knowledge of applicable regulatory regulations and requirements
? Strong technical writing skills
For further information on this IS Lead Analyst role in Cork please contact Bridin Quinn on 091730022 / email@example.com
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