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QA Compliance Specialist

Indianapolis, IN 46241

Posted: 11/16/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 577594 Is job remote?: No Country: United States

Job Description

Pay Rate: $76.40 - $86.18
 
The QA Compliance Specialist implements robust Quality Systems for Indianapolis considering and regulatory requirements of the organization. This role contributes significantly to the execution of these systems, authors or contributes to the procedures governing these systems and works towards timely implementation, including experience in Quality Management Review, Self-Inspection and in the execution of health authority inspections.
  • Supports the development and oversight of robust quality systems, including both implementation and operation at site level.
  • Leads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate.
  • Works with the management team to implement and execute the Inspection Readiness program; including Corporate Inspections and Global Health Authority Inspections.
  • Facilitates training on all QA Compliance programs.
  • Supports management to implement and maintain the following programs; Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Global document assessments required to be performed at the site level.
  • Contributes significantly to the site inspection preparation, program management, response and commitment process.
  • Administers the site training program.
  • Escalates high quality risks per procedure and supports agency notifications such as Field Alerts.
  • Performs duties as assigned to ensure compliance to global and local regulations.
  • Represent QA Compliance on project teams and in meetings.
  • Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations.
  • Adheres to all GMP requirements.
  • Other related duties as assigned.

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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