Job Description

Role: QA Investigator

Duration: 6+ Months

Key Responsibilities:

Process Ownership & Governance:

• Serve as the global process owner for Deviation, CAPA, Change Control, and Training processes, ensuring seamless integration and alignment with business operations.
• Maintain and update the Global Quality Manual and Quality Policy to ensure compliance with regulatory requirements and alignment with evolving business needs.
• Lead regular reviews and effectiveness assessments of critical processes to drive continuous improvements and optimize operational efficiency.
• Oversee the management of Quality Systems deviations and CAPAs, ensuring comprehensive investigations, timely resolutions, and implementation of effective preventive actions.

Training Management:

• Manage the development and execution of annual GxP training programs for employees across the organization.
• Oversee the entire GxP training lifecycle, including needs assessments, content development, delivery, and compliance tracking.
• Measure and ensure training effectiveness through appropriate assessment tools, metrics, and feedback mechanisms.
• Collaborate with subject matter experts and business stakeholders to design, maintain, and enhance training content and GxP curricula.
• Represent the GxP training process during inspections, working closely with the Learning Management System (LMS) owner to ensure readiness.
• Oversee and/or act as QA on CAPAs and deviations associated with the training process.
• Design and facilitate onboarding activities related to Quality, ensuring new hires are fully integrated into the company's quality culture and standards.

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