Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel,Cootehill, Donegal, Longford andSligoand a third-party manufacturing management operation inSligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs almost 4,000 people across nine sites.
We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo.
Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
ABBOTT BUSINESS TECHNOLOGY SERVICES AT CHERRYWOOD
Abbott Information Technology (IT) is responsible for delivering Information technology solutions and services to over 130+ countries globally.
To support this global footprint, Abbott IT is building a new team in Ireland located in Cherrywood, Dublin. The newly established hub will be a strategic location
for technology talent, delivering regional programs and supporting global operations for critical services.
Individual contributor Software Quality Assurance Engineer, who ensures that SLC validation package documentation complies with policy and procedure requirements in conjunction with business, regulatory and technology requirements. An individual with comprehensive knowledge of Iterative methodologies and experience supporting a global IT delivery team to ensure awareness of expectations.
Responsible to define, harmonize and implement value-added risk-based validation strategies to optimize the efficiency and effectiveness of associated processes.
Reviews and approves SLC deliverables in accordance with Abbott policies, procedures as well as global regulatory requirements
Provides IT validation packages in compliance with applicable Corporate and Divisional Policies and procedures
Works autonomously with related IT contacts and the business process SMEs for this purpose.
Supports IT delivery teams as SQA engineer lead for the automated testing and implementation of regulated IT applications, both GxP and non-GxP
Ensures continuous improvement and gives input related to the validation strategy, both Agile and waterfall, for IT changes
Coordinates the introduction of new strategic methodologies; supports and approves the overall validation of global regulated applications
Defends the validation strategies to internal auditors, regulatory authorities and other certified bodies
Drives the GXP Inspection Support process to assist Abbotts Divisions & Affiliates during GXP audits
Provides IT validation subject matter expertise
Tracks and reports validation progress of projects through available tracking tools
Apply SQA Engineering principles throughout the Agile product life cycle to identify defect and design flaws
Collaborates with the IT delivery team to build compliance capabilities to assure the quality of the deliverables and ensures business needs are met
The role must be familiar with Quality Risk Management principles and practices; guide delivery teams and management with risk-based decision-making capabilities
The role must be familiar with Good Documentation Practices and assist as appropriate with required documentation for compliance purposes
EDUCATION & COMPETENCIES:
Bachelor's Degree in Science or equivalent or Information Technology or equivalent plus 6+ years of related work experience with IT Quality in the life science industry, or an equivalent combination of education and work experience
ASQ Certified Software Quality Engineer qualification, certified in ISO9001 or ISO13485 preferred
Experience of IT Regulatory Compliance (21 CFR Part 11, EU Annex 11, GXP), Computer System Validation (IQ/OQ/PQ) and SQA needs for Lifesciences industry.
Strong knowledge of GXP regulations and validation principles
Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner
Highly self-motivated, goal orientated, and self-directed
Familiarity with risk management principles, regulatory requirements and, industry best practices.
Familiarity with Agile Scrum, Kanban, or Lean software development practices
Experience working in Waterfall and Agile engineering environments
Demonstrated ability to operate and innovate in a small team with a fast‐paced environment, balancing both strategic and tactical needs.
Familiarity with automated testing and implementation
Familiarity with JIRA, Selenium, Bitbucket, HP ALM and/or other tools
Flexibility to adapt to changing assignments and ability to effectively prioritize
Effective with written and verbal in English communications at all levels, providing input and regulatory guidance to project teams, management and business partners
The role must maintain compliance expertise and be effective at applying requirements into the IT and business environment that supports business goals and maintaining a compliant state.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.