CSV - Quality Control
- Daman, Daman & Diu
- Permanent
- Full-time
- Prepare and review validation documentation (URS, Risk Assessment, IQ/OQ/PQ protocols, traceability matrix, validation reports) for computerized systems used in QC.
- Ensure compliance of QC systems with applicable regulatory and data integrity requirements.
- Collaborate with QC Analyst, IT, QA, and equipment / software vendors for implementation and validation of instruments and associated software (e.g., HPLC, GC, UV. Dissolution systems).
- Coordinate periodic review of validation systems, including assessment of audit trails and system access controls.
- Maintain validation state of systems through change control, deviation management, and revalidation activities.
- Support in qualification of new laboratory instruments and their integration with LIMS or standalone use.
- Assist during regulatory audits and inspections related to data integrity and system validation.
- Provide training and awareness to QC Staff on validation systems and data integrity practices.