01Key Responsibilities
Plan, prepare, and execute validation activities for GxP-regulated applications.
Review User Requirements Specifications (URS), Functional Specifications (FS), and Design Specifications (DS).
Develop and execute IQ, OQ, and PQ protocols.
Prepare validation documentation, including Validation Plans, Traceability Matrices, and Validation Summary Reports.
Design and execute functional, regression, integration, and User Acceptance Testing (UAT) test cases.
Verify compliance with GxP regulations, GAMP 5, 21 CFR Part 11, and EU Annex 11.
Perform risk assessments and support risk-based validation activities.
Document test evidence and maintain complete validation records for audit readiness.
Identify, log, and track defects, ensuring timely resolution with development and business teams.
Support change control, deviation management, and CAPA activities.
Collaborate with quality assurance, validation, business, and technical teams throughout the validation lifecycle.
Participate in internal and external audits by providing validation documentation and evidence.
Ensure all validation deliverables comply with organisational SOPs and regulatory requirements.
Contribute to continuous improvement of validation and testing processes.
Minimum Qualifications:
Desired Qualifications (Optional):
Location: PUNE/ GURGAON
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