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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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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