Back to jobsDevelop, review, and approve CSV documentation including Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Test Plans, IQ/OQ/PQ protocols, and Validation Summary Reports.
Ensure validation activities comply with applicable regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
Participate in system implementation projects to ensure validation requirements are met from planning through deployment.
Perform QA oversight for IT systems used in GMP environments, including Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and Enterprise Resource Planning (ERP) systems.
Initiate, Review and approve change controls, deviations, CAPAs, and audit trail reviews related to computerized systems.
Ensure systems are maintained in a validated state throughout their lifecycle.
Author and maintain Standard Operating Procedures (SOPs) related to CSV, data integrity, and IT compliance.
Ensure documentation practices align with ALCOA+ principles and data integrity standards.
Support internal and external audits by providing documentation and subject matter expertise on validated systems.
Address audit findings and implement corrective actions related to IT systems and CSV.
Work closely with IT, Manufacturing, Quality Control, and Regulatory Affairs to ensure systems meet business and compliance needs.
Provide training and guidance to stakeholders on CSV and data integrity requirements.
Conduct risk assessments for computerized systems to determine validation scope and testing rigor.
Identify and mitigate compliance risks associated with IT systems.
Stay updated on regulatory trends and industry best practices in CSV and data integrity.
Recommend improvements to validation processes and system lifecycle management.
