Sr Quality Specialist

at  Thermo Fisher Scientific

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

EDUCATION

• Bachelor’s Degree or higher in Science, Engineering or QA/Regulatory related area of study

EXPERIENCE

• At least 10 years prov experience in a GMP regulated industry, preferably pharmaceuticals, with direct experience in Validation or Quality

KNOWLEDGE, SKILLS, ABILITIES

• Knowledge of FDA/EMA regulatory requirements applicable to computerized systems used for pharmaceutical production. Ability to apply GMP regulations and other international guidelines to all aspects of the position.
• Strong sense of vision and direction for process areas related to electronic master batch release, batch execution, review by exception, critical process parameters, batch report and real time release.
• Understanding of the lifecycle phases for IT systems: development, maintenance, compliance management, decommissioning, and risk management.
• Strong interpersonal and communication skills: written and oral.
• Ability to collaborate with contractors and internal technical groups regarding IT compliance and Quality issues across a network of global sites and multiple time zones.
• Assertive assurance of Quality throughout all operations and the ability to make key decisions.
• Drive operational excellence with a continuous improvement mentality.

PHYSICAL REQUIREMENTS / WORK ENVIRONMENT

• Proficient with computer (MS Office Suite) and internet skills with a solid understanding of controlled documentation and data systems.
• Up to 25% domestic and/or international travel may be required.

Please refer the Job description for details