Description

Role description

• QR lead with 10+ years of testing experience and for a life sciences customer, ensuring quality across validated systems.
• Strong working knowledge of GxP (GMP/GLP/GCP) regulations and compliance requirements.
• Hands-on experience with CSV testing, including IQ/OQ/PQ documentation and execution.
• Manage test planning, execution, and defect tracking using JIRA and HP ALM.
• Exposure to test automation frameworks to drive efficient regression/validation cycles.
• Coordinate with client QA, IT, and business stakeholders to align on timelines and deliverables.
• Ensure test scripts, traceability matrices, and validation reports are audit-ready.
• Experience with deviations, CAPAs, and change control in validated environments.
• Bridge offshore delivery teams with onsite client expectations; strong stakeholder management.
• Prior experience in pharma, biotech, or medical device domains preferred.

Skills

ALM

JIRA

GxP

Key Skills

Education

Any Graduate