Commit to, support and implement the Data Integrity Program
Apply the Data Integrity regulations as described a.o. in Eudralex vol 4., FDA 21 CFR
part 11, ISPE guidelines, WHO annex 5, as well regulations as described in the guidelines, SOPs, work instructions,
Train and coach staff, if required, in the defined departments according to SOPs, works instructions and toolkit,
Implement DI Activities in the context of the Data Integrity Implementation Program (create process flows, data flow diagrams, IT systems gap assessments, risk assessments as well as remediation activities for defined processes and systems as per tool kit),
Remediation Activities in the context of Data Integrity Implementation Program,
Document these activities/results as per Good Documentation Practices and SOPs and guidelines,
Report to the DI PPO (primary process owner) or delegate on a regular basis.
Comprehensive Data Flow Diagrams (documented), System Assessments (documented), Risk Assessments (documented),
Remediation support for various departments, systems and (investment) projects of DBO including the agile DI Team,
Continuous improvement of the Data Integrity Maturity Level of the specific department through adherence of defined milestones,
Average of 5 to 10 years of hands-on Lab experience
Proven experience (process/equipment) with data integrity in a Lab environment
Good Documentation Practice in Pharma and Biotech domains,
Solid experience with GxP regulations both FDA as well as EU,
Interested? Send your CV to email@example.com ASAP as this is time sensitive; or call me on +31 2020 44 502.