Description:
Monitoring each GLP study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLP regulations (21 CFR Part 58).
Assessing Vendors for GLP Compliance and monitoring studies performed at the vendors.
Providing audit reports for audits / assessments performed.
Provide Compliance Oversight and training to internal personnel.
Perform internal GLP activities to conform with the GLP regulations (21 CFR Part 58)
Maintaining a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the site that is indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.
Maintaining copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible.
Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.
Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
Additional Skills & Qualifications:
Minimum Bachelors Degree
GLP experience
Preferred auditing experience
Cytotoxicity lab experience preferred
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
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