QA Compliance Specialist
8520 Challenger Drive Indianapolis, IN 46241 US
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.
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