Published: June 3, 2020
- Responsible for ensuring systems comply with data life cycle requirements from initial data creation/recording to archival and decommissioning. This includes, but is not limited to, data management (e.g. data creation, data processing, re-processing, review, reporting), data security, data traceability/process mapping, data backup/restore, electronic signature/electronic record linking and data audit trails.
- Responsible for conducting data integrity assessments of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements and company established requirements for data integrity.
- Responsible for partnering with colleagues across all GO NAM sites in the identification of data integrity solutions to ensure consistent and effective compliant processes are implemented.
- Responsible for preparing mitigation and remediation strategies when data integrity gaps are identified.
- Responsible for conducting data integrity periodic reviews and performing risk monitoring of implemented systems to ensure continued compliance.
- Responsible for leading investigations and implementing corrective/preventative actions associated with data integrity events.
- Executes data integrity processes for automated systems in conjunction with computerized system development life cycle (SDLC) methodologies to ensure computerized systems meet regulatory requirements, company requirements and align with industry standards.
- Collaborates with GO NAM sites to ensure a consistent and harmonized data integrity approach across all sites.
- Responsible for the authorship and review of effective Standard Operating Procedures associated with data integrity compliance.
- Responsible for conducting training on data integrity and associated processes.
- Maintains awareness of data integrity regulatory actions (FDA 483s and Warning Letters), current regulatory trends and their impact on existing systems and recommends internal process improvements.
- Seeks out and recommends to management opportunities for increased data integrity program efficiencies and operational improvement through modifications to current systems, implementation of new systems and more efficient use of established systems.
- Work experience in GxP regulations and Good Automated Manufacturing Practices (GAMP) principles with an emphasis in 21 CFR Part 11, 210, 211, 58 and 820.
- Work experience in managing multiple projects of varying degrees of complexity.
- 3-5 years of work experience in manufacturing operations within the Pharmaceutical/Medical Device Industry.
BS in Computer Science, Computer Engineering, Mathematics or in a science-related field.