On that role, you will ensure compliance with electronic data integrity (e-DI) processes in QC laboratories and Manufacturing. This includes performing QA oversight, reviewing audit trails, approving CSV/Qualification documents for equipment (e.g., HPLC, GC, MES), and defining critical data flows to maintain QA integrity. You will also support KPI maintenance and act as an e-DI expert within the organization.
Key Responsibilities:
* Review and approve e-DI deliverables such as URS, FRA, and qualification reports in alignment with current guidelines.
* Approve equipment qualification reports and audit trails according to GxP standards.
* Perform electronic data reviews on manufacturing and QC laboratory equipment.
* Simplify and streamline processes to remove obstacles and support continuous quality improvements.
* Contribute to quality strategies ensuring data integrity for assigned projects.
* Participate in the implementation of new e-DI SOPs and ensure compliance with GxP standards.
* Enforce stakeholders' adherence to electronic data integrity processes.
* Coordinate with internal and external stakeholders, including CMOs, to manage product-related deviations, change controls, investigations, and incidents.
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