Job Description:
At Abbott, you will play a crucial role in helping people live more fully at all stages of their lives. The company is a global healthcare leader with a diverse portfolio of life-changing technologies.
About Our Company:
Our organization spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products, and branded generic medicines. We have a significant presence in Ireland, employing over 6,000 people across ten sites.
Diabetes Care Kilkenny:
Our new manufacturing facility in Kilkenny is a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals. It produces life-changing technologies that enable people with diabetes to live the best and fullest lives they can.
Main Responsibilities:
* Define software validation strategy for specific projects in alignment with corporate procedures.
* Draft or collaborate on software project validation pre-requisites such as validation plans, 21 CFR Part 11 assessments, software risk assessments, and requirement traceability matrices.
* Generate and execute validation protocols and associated reports for Software Validation Activities and technical reports related to equipment, products, and/or processes.
* Provide necessary documentation and support during internal and external audits.
* Offer technical support and guidance on system requirements and validation processes as required.
* Provide direction and mentoring to junior team members.
Requirements:
* NFQ Level 7 Qualification in Engineering/Science or Equivalent.
* 5 Years experience in a similar environment.
* Project management experience, ability to work to pre-agreed schedules and report on progress to management.
* Lead investigations into validation anomalies or deviations and apply problem-solving methodologies to arrive at and implement corrective actions.
* May assist with establishing corporate validation policies.
* Strong understanding of GAMP5 and regulatory requirements.
What We Offer:
* Attractive compensation package that includes competitive pay, benefits, career development opportunities, and access to many more benefits.