Sr Quality Specialist - Computer System Compliance

Location

North Carolina | United States

Job description

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.

Location/Division Specific Information

The Computer System Quality Assurance Team provides quality oversight of business enterprise applications within the Pharmaceutical Services Group (PSG) of Thermo Fisher Scientific, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to data integrity, computer system lifecycle activities, and change management. We support a global business network, collaborating with Quality, IT, and business groups to support multi-functional projects and continuous improvement initiatives.

Discover Impactful Work:

This position is Quality Specialist – Computer System Compliance

In partnership with various IT groups and PSG sites, work to support computerized system compliance for MES (Manufacturing Execution Systems), setting the program level strategic vision for the standardization of Quality related aspects of an MES solution.

A day in the Life:

• Optimize the PSG MES Validation strategy to standardize and harmonize the global MES CSV standards, templates and approved global documents that can be applied by the manufacturing sites.
• Provide Quality Assurance oversight for PSG computerized systems for the entire system lifecycle from infrastructure qualification through application validation and maintenance.
• Review and approve required GMP records, ensuring compliance and procedural requirements are met.

Keys to Success:

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.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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