Senior QA Compliance Auditor Drug Development 6873

Company: True North Consulting LLC
Location: Indianapolis
Posted on: November 19, 2023

Job Description:

Senior QA Compliance Auditor Drug Development 6873 Apply Location Indianapolis, IN
Type Contract ID BU82-2729289 Posted Oct 20, 2023 This is a contract job opportunity. potential for perm Position: Senior QA Compliance Auditor Drug Development 6873 Location: Indianapolis IN Schedule: 1st shift Job code: CVDJP00026873 Benefits are available Candidates will need to go into office. Will definitely need to be in office for audits and other required days Summary: The main function of a compliance analyst is to ensure the organizations operations and procedures meet government and industry compliance standards. A compliance analyst may research regulations and policies, communicate requirements, and apply for compliance certifications on behalf of the organization. Job Responsibilities: Researching industry compliance regulations and policies. Evaluating internal operational and procedural compliance. Analyzing and updating existing compliance policies and related documentation. Communicating compliance policies and guidelines to Management and designated departments. Developing and executing new compliance policies and procedures as required. Applying for compliance certification and regulatory approval. Developing and maintaining a compliance recordkeeping system. Training employees on industry compliance requirements. Maintaining communication with compliance regulators and following up on applications. Keeping up with compliance requirements and amendments to regulations. Requirements: Industry related bachelors degree or related experience. Compliance management certification preferred. Knowledge of compliance management software. Advanced analytical abilities. Good communication and interpersonal skills. 5-7 years of experience. - Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representativesample) - Contributes to global QA policies on interpretation/ application ofregulations. - Provide subject matter expertise to projects Support team in CAPA plancreation. - Hosts external audits/inspections e.g., regulatory inspections, strategic clients. Assists with the facilitation of auditresponses. - Supports the QA-to-QA relationship with keyclient(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 QAorganization. - Supports the reporting of quality metrics and implementation of necessary correctiveactions and/or process improvements via appropriate forum (e.g., Monthly Reports, Site Quality Review, Liaisonmeetings) - Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, asindicated in applicable controlled documents, arefollowed. - Other duties as assigned bymanagement. - 5 years in regulatory environment (experience in GXProles) - Experience of industry qualitysystems/standards - Excellent interpersonal/organizational skills, e.g., communication, decisionmaking, negotiating, problemsolving - Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiplescenarios. Recommended: - A minimum of a bachelor's degree in a Pharmacy, Chemistry or Biology relateddiscipline - Postgraduate degree (MSC or equivalent) in science or management relateddiscipline, preferable - Experience may be substituted foreducation.
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Keywords: True North Consulting LLC, Indianapolis , Senior QA Compliance Auditor Drug Development 6873, Accounting, Auditing , Indianapolis, Indiana