Job Description Summary
The Sterility Assurance & Compliance Scientist role is a technical and compliance position, that develops and implements the site’s sterility assurance related initiatives and ensures efficient and cost-effective Sterility Assurance compliance. Primary objectives include the implementation of sterility assurance strategies, cleaning validation, periodic monitoring, product sterilisations, component sanitisations and sterility assurance risk management. The role also encompasses developing, implementing, managing and continually improving Sterility Assurance activities to ensure GE Healthcare is in compliance with current regulatory requirements.This will be a Fixed term (Maternity leave cover) contract for 12 months.
Job Description
MAIN DUTIES AND RESPONSIBILITIES:
Understand the scientific principles required for terminal sterilisations and sterility assurance level required in manufacturing parenteral products.
Understand cleaning principles required to maintain existing manufacturing and process trains in a validated state.
To be fully conversant with GMP requirements for Sterility Assurance compliance and parametric release at GEHC Cork site.
To become familiar with Annex 1 requirements with regard to Sterility Assurance and Cleaning Processes.
Manage the annual Thermal Validation and cCleaning compliance trackers.
To be the site sterilization deputy as defined in the Sterilisation Monograph.
Deputise for the Sterility Assurance Lead / Manager as required.
To participate and represent the SA group at GMP Audits.
Assist and support SME’s in establishing root cause investigations related to sterility assurance and cleaning programs.
Create, execute, review, and/or approve technical documents related to sterility assurance and cleaning programs and studies.
Evaluate change controls related to sterility assurance and cleaning programs.
Ensure compliance with current technical, engineering and regulatory standards and guidelines.
Perform periodic review of sterility assurance and cleaning procedures.
Perform Annual product reviews.
Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities
PRINCIPAL QUALIFICATIONS/SKILLS AND WORK EXPERIENCE REQUIRED:
Graduate in an Engineering or Science discipline or equivalent.
Post Graduate Qualification or equivalent.
Good PC Skills and Computer literate.
Good communication and motivation skills.
Experience supporting cGMP manufacturing (specifically within operations, sterility assurance validation, cleaning validation, microbiology and chemistry laboratory results, quality assurance, etc.)
A minimum of two years experience in a similar role is desirable.
Additional Preferences & Competencies:
Good knowledge of bioburden reduction and cleaning processes.
Strong interpersonal and teamwork skills
Strong self-management and organizational skills
Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization.
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.
Behaviors
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.
Total Rewards
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.
Additional Information
Relocation Assistance Provided: No