You are responsible for quality oversight of GMP-relevant computerized systems throughout the entire system lifecycle.
You review and approve CSV documentation (e.g., Validation Plans, Risk Assessments, Test Documentation, Traceability Matrix, Reports)
You ensure the GMP-compliant implementation, qualification, and operation of computerized systems.
You evaluate and approve changes to GMP-relevant systems as part of the change control process.
You ensure compliance with data integrity requirements according to ALCOA+ and assess risks related to electronic data, audit trails, and electronic signatures.
You support investigations into data integrity deviations and define and track CAPA measures accordingly.
You will accompany internal audits and regulatory inspections, ensure permanently auditable documentation, and conduct gap analyses and compliance reviews.
You advise and train stakeholders on GMP, CSV and data integrity requirements and drive the continuous improvement of quality processes and standards.
Responsibilities
You are responsible for quality oversight of GMP-relevant computerized systems throughout the entire system lifecycle.
You review and approve CSV documentation (e.g., Validation Plans, Risk Assessments, Test Documentation, Traceability Matrix, Reports)
You ensure the GMP-compliant implementation, qualification, and operation of computerized systems.
You evaluate and approve changes to GMP-relevant systems as part of the change control process.
You ensure compliance with data integrity requirements according to ALCOA+ and assess risks related to electronic data, audit trails, and electronic signatures.
You support investigations into data integrity deviations and define and track CAPA measures accordingly.
You will accompany internal audits and regulatory inspections, ensure permanently auditable documentation, and conduct gap analyses and compliance reviews.
You advise and train stakeholders on GMP, CSV and data integrity requirements and drive the continuous improvement of quality processes and standards.
Linked-in
Google