General Electric QC specialist - Fixed term 18 months in Cork, Ireland
Job Description Summary
As a QC Specialist you'll provide technical support to the QC department, ensure QC systems, instrumentation and processes are compliant, effective and implemented.
Lead Data Integrity Projects for QC.
Familiar with 21 CFR part 11 and how it applies to laboratory instrumentation
Sourcing, purchase and qualification of laboratory equipment
Review industry and regulatory standards & guidelines to ensure equipment is installed, qualified to current standards.
Support method validation activities, through writing and executing protocols
Support Equipment associated IR’s and Investigations for QC.
Lab system admin for QC Chemistry Equipment.
Perform system audit trail reviews on QC Equipment.
Support Method transfers for QC.
Support LIMS and MODA maintenance, validation and end user support.
Support regulatory assessments as requested.
Annual Periodic reviews of QC Chemistry systems.
Complete review/approval of validation documentation for other team members on request.
Support QA Agreements for all equipment vendors.
Complete Manual daily backups as required
Audit support for equipment-related preparation and response.
Support analytical testing if required.
Research new technologies to improve laboratory compliance and efficiency
Qualifications and experience
Degree (or equivalent) in Chemistry / Microbiology, or in a Science/Engineering subject
Familiar with Regulatory and ICH expectations of good laboratory practices, equipment qualification and maintenance.
Familiar with QC systems and processes, especially LIMS, MODA & Veeva.
Strong theoretical and practical knowledge of QC equipment qualification and maintenance.
Experienced in data compilation, review and report generation
Experienced in Data Integrity requirements for QC.
Project Management - leading & oversight as well as contributory role.
Familiar with Validation lifecycle, Computer System Validation, Annex 11, Data Integrity, GAMP & 21 CFR Part 11 requirements.
Works in an organized manner
Works independently and seeks solutions
Clear thinker and disposed for troubleshooting
Good understanding of how work of own team integrates with other teams
Contributes when working in cross functional groups
Maintains a latitude to rearrange the sequence to complete task/duties based on changing work situations
Flexible, self-motivating, quickly familiarize themselves with new problems and responsible
•A good level of English and a valid Work Permit
Inclusion and Diversity
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 expression, 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.
Relocation Assistance Provided: No