Found Description
Overview
Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems. Perform risk assessments and impact analyses related to system validation. Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborate with IT, Quality Assurance, and Manufacturing teams to support system qualification and validation activities. Manage change control and deviation investigations related to validated systems. Support audits and inspections by regulatory authorities. Maintain validation documentation and ensure traceability throughout the system lifecycle.
Responsibilities- Develop and review validation plans, protocols, and reports for computerized systems (IQ, OQ, PQ).
- Perform risk assessments and impact analyses related to system validation.
- Ensure compliance with regulatory guidelines (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
- Collaborate with IT, Quality As...