Engineer Iii Qa Job In Cork

Seeking an Analytical Development Scientist to conduct method development, validation, and transfer of quality methods, and drive innovative ideas for new quality assurance methods.

Thermo Fisher Scientific is a leading global biotechnology company that enables our customers to make the world healthier, cleaner, and safer.

Responsibilities:

• Conduct method development, validation/qualification, and transfer of quality methods.
• Prepare, review, and update quality methods and specifications.
• Compile QC handover packages and provide technical support during method familiarization and validation periods.
• Drive innovative ideas for new quality assurance methods and continuously optimize existing ones.
• Collect, interpret, and characterize quality data through accurate documentation of experimental results.
• Prepare and review quality-related change controls, study protocols, project status reports, and other relevant documentation.
• Expand your scientific and technical knowledge by knowing the latest in peer-reviewed literature, attending conferences, and participating in relevant training.
• Ensure timely project delivery while meeting technical, quality, and safety metrics.
• Perform all quality, regulatory, and safety duties with due care, aligning with our values: Integrity, Intensity, Innovation, and Involvement.

Quality Responsibilities:

• Perform duties with the highest standard of accuracy and in strict accordance with our Quality Management System requirements and Global Quality Policies.
• Fully engage in our site's quality initiatives and ensure alignment with all relevant standards.
• Attend training sessions and complete assessments to improve your skills and knowledge.
• Follow GMP quality compliance and always be inspection-ready.
• Demonstrate behaviors that we value, including effective communication, facilitation, and presentation skills.
• Exhibit leadership qualities, influencing and negotiating skills, and a positive, can-do approach.
• Possess the ability to coach, empower, train, and mentor others.

Knowledge/Education/Experience Required:

• Minimum Level of Education: Bachelor's Degree in Chemistry or Analytical Chemistry, or equivalent experience.
• Preferred Level of Education: Master's Degree in Chemistry or Analytical Chemistry, or equivalent experience.
• Job-related experience within the pharmaceutical industry.
• Up-to-date knowledge of Quality guidelines (e.g., ICH, FDA, IMB, QMS, and GMP).
• Experience in project/people management for technology transfer projects.
• Sound technical knowledge of your specific field and a good understanding of critical on-site business functions.
• Detailed knowledge of c GMP requirements and Thermo Fisher Scientific's Quality Policies, Management Procedures, and Guidelines.
• Familiarity with the Cork Risk Management System, CAPA's, project planning & management.
• Excellent written and verbal communication skills.