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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.

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

? 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
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