it-qc

4 weeks ago

Ahmedabad, India Veeda CR Full time

Key Responsibilities:

Audit Readiness (IT Focus)

  • Ensure IT systems, documentation, and infrastructure are always audit-ready for external and internal audits.
  • Lead or support IT-related audit sessions, walk-throughs, and responses during sponsor audits, regulatory inspections, and internal QA reviews.
  • Maintain an organized repository of IT evidence including SOPs, validation documentation, access logs, and change control records.

IT Compliance & Documentation

  • Author, review, and maintain IT SOPs, Policies etc. in accordance with regulatory requirements.
  • Ensure that IT documentation complies with 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
  • Conduct periodic reviews of IT systems and documentation to identify gaps or outdated materials.
  • Complete the RFI related to IT

Support for Regulated Systems

  • Work closely with business users, QA, and CRO staff to ensure that electronic records, and data storage systems meet compliance and audit expectations.

Audit Trail & Data Integrity Monitoring

  • Regularly review audit trails, user access logs, and backup records for critical systems.
  • Conduct IT self-inspections and participate in internal data integrity assessments.
  • Handling the Process related to GDPR
  • Ensure adherence to ALCOA+ principles and manage risk-based reviews of electronic systems.

Change Control & Deviation Handling

  • Participate in change control processes involving IT systems and infrastructure.
  • Investigate and document IT-related deviations, incidents, and CAPA actions in collaboration with QA and stakeholders.

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