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GLP Auditor
900 Ridgebury Rd Ridgefield, CT 06877 US
Job Description
To implement the Regulatory Compliance Program designed to assure the adherence of facilities, operations, studies, reports and practices to regulations (e.g. FDA, EMEA, NRC, DEA USDA) as well as to Standard Operating Procedures (SOPs), internal policies, regulatory guidelines and good scientific and documentation practices. To inform Management of deviations from the cGMP, GLP, other Regulations observed during audits/inspections, to recommend appropriate corrective action when necessary and to verify that appropriate corrective actions have been implemented that adequately address any deviations reported during inspections.
Duties & Responsibilities
- Review procedures for compliance to GxP requirements and Company standards
- Conduct audits to support GLP studies (e.g. protocol, amendment, study data, Principal Investigator reports such as Toxicokinetic reports, etc.)
- Issue electronic audit reports and perform follow-up actions
- Scan study records to facilitate audit requests
- Monitor and update electronic system with new audit requests
- Update the GLP Master Schedule as needed
- Conduct internal facility audits as needed
- Provide support during corporate audit and regulatory inspections as needed
Requirements
- GLP Auditing or comparable experience
- Intermediate knowledge of relevant regulations and guidance
- Works independently with moderate guidance
- Excellent conflict resolution and negotiation skills
- Good organization skills
- Good to excellent verbal and written communication skills
Desired Skills, Experience and Abilities
- Previous GLP Auditing Experience is preferred
- Previous Toxicokinetic/Bioanalytical experience is preferred
- Bachelor´s Degree or equivalent with 3 years of Pharma experience or equivalent
Pay Rate Range: $30-36/hr depending on experience
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Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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