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Compliance Analyst III

Indianapolis, IN 46214

Posted: 02/02/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 532848 Is job remote?: No Country: United States

Job Description

Essential Job Duties:
? Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)
? Contributes to global QA policies on interpretation/ application of regulations? Provide subject matter expertise to projects Support team in CAPA plan creation
? Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses
? Supports the QA–to-QA relationship with key client(s)
? Delivery of training in performance of audits (basic, intermediate, complex)
? Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization
? Supports the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings)
? Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
? Other duties as assigned by management.

Experience:
Minimum Required:
? 6 years in regulatory environment (experience in GXP roles)
? Experience of industry quality systems/standards
? Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving
? Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios

Education:
Recommended:
? A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline
? Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable
? Experience may be substituted for education

The staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. 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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Although this hasn't been an issue at The Planet Group, the staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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