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Cork, Éire / Ireland
Onsite
Available
Own and continuously improve CSV and Data Integrity procedures, standards, templates and governance processes.
Maintain and periodically review the site inventory of GxP computerized systems.
Ensure computerized systems validation activities are performed in accordance with site procedures, regulatory requirements and industry best practice.
Work closely with Engineering, Quality, Operations, IT and external vendors to ensure validation deliverables meet site and regulatory requirements.
Develop and approve validation strategies, validation plans, risk assessments, requirements specifications, test protocols and validation summary reports as required.
Ensure appropriate application of Computer Software Assurance (CSA) and risk-based validation methodologies.
Maintain Requirements Traceability Matrices and Data Lifecycle documentation for applicable systems.
Lead Data Integrity assessments, gap analyses and continuous improvement initiatives.
Promote compliance with ALCOA+ principles and Data Integrity requirements across site functions.
Ensure appropriate change management processes are followed for computerized system introductions, upgrades and modifications.
Develop and execute Change Controls and TrackWise records for computerized systems where required.
Review and approve vendor validation documentation and ensure supplier deliverables satisfy site requirements.
Support and attend Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), commissioning and qualification activities as required.
Lead or support periodic reviews to ensure computerized systems remain in a validated state.
Monitor developments in regulations and industry guidance including Annex 11, 21 CFR Part 11, GAMP 5, Data Integrity Guidance and CSA practices.
Maintain awareness of evolving regulatory and industry expectations & best practices and ensure timely implementation into site procedures and practices.
Serve as SME during regulatory inspections, customer audits and internal audits.
Support audit preparation activities and lead responses to computerized system and Data Integrity observations.
Provide technical leadership and mentoring to Engineering, Automation, Quality and Operations personnel in CSV and Data Integrity best practices.
Work collaboratively to ensure key commitments, project milestones and compliance objectives are achieved.
Required to comply with Procedures and Guidelines, regulatory requirements and execute cGMP in the performance of day-to-day activities and all applicable job functions.
Relevant qualification (Degree) in Engineering, Computer Science, Life Sciences or a related discipline.
Strong experience in pharmaceutical, biotechnology, medical device or other regulated manufacturing environments.
Significant experience leading Computerized Systems Validation activities across the full computerized system lifecycle, from concept and implementation through operation, periodic review and retirement.
Strong knowledge of Data Integrity principles, data lifecycle management and ALCOA+ requirements.
Thorough understanding of regulatory requirements relating to computerized systems and electronic records, including EU GMP Annex 11, FDA 21 CFR Part 1, GAMP 5, Data Integrity Guidance (FDA, MHRA, PIC/S) & Computer Software Assurance (CSA) methodologies
Experience delivering and approving complete validation documentation packages.
Experience validating automation and manufacturing systems including DCS, PLC, SCADA, BMS, Historian and related GxP systems is desirable.
Excellent verbal and written communication skills.
Strong analytical and problem-solving skills.
Demonstrated ability to influence cross-functional teams and provide technical leadership.
Ability to work independently and manage multiple priorities in a regulated environment.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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Relocation Assistance Provided: No