CSV - Quality Control

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.