Job Description

Your responsibilities:

1. Framework & Policy

  • Write and review policies, procedures, and controls that ensure ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available) are embedded throughout the organization.

    • 2. Audit & Assessments

  • Participate in internal audits and execute internal audits. Perform data integrity gap assessments and perform and lead risk assessments for all GMP processes and systems at Prothya.

    • 3. Compliance Monitoring

  • Ensure all GxP-related systems and processes comply with regulatory expectations and company policies regarding data integrity.

    • 4. Training & Awareness

  • Develop and deliver training and training materials to increase awareness of data integrity principles among staff across departments

    • 5. Corrective and Preventive Actions (CAPA) and Change Control

  • Investigate data integri...

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