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Job ID :
53365BR
Location :
US - Massachusetts - Franklin
:
Job Description
DUTIES:
Support the continued development of Good Manufacturing Practice (GMP) capability and maintenance of compliance to U.S. FDA Quality System Regulations.

Assist in overall GMP strategy, best practices, and guidance cross multiple GMP sites.
Support Software compliance—develop and review User/Functional requirements, test scripts, and validation plans.
Support Equipment Compliance – assist in equipment maintenance and validation review.
Support the internal audit program and conduct audits of internal processes related to the overall Quality Management System.

REQUIREMENTS:
Master’s degree in Biology, Chemistry, Pharmacy or related field of study plus 3 years of GMP management or related experience. Employer also accepts a Bachelor’s degree plus 5 years of experience as an equivalent alternative.

Must have experience or knowledge of:

GMP and cGMP;
Medical devices and pharmaceuticals;
Pharmaceutical regulations;
Software compliance;
Microsoft Office;
Trackwise; and
Sharepoint.

TRAVEL: Less than 10% of domestic travel only



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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