The role is responsible for ensuring Process Validation activities are performed in a
consistent and controlled manner to support the manufacture of Drug Substance.
Support Process Validation project activities at ARI
Support the development of Process Validation/Process Performance Qualification strategy for New Products,
ensuring alignment with regulatory guidelines and industry standards
Support the execution of validation projects and/or protocols and the collection of data to support completion of Process
Review requirements and source process design and execution documentation for use in development of process
Develop/Update appropriate Validation Master Plans
Develop and author Validation protocols/reports
Author validation sections for Regulatory filings and/or provide data verification
Provide guidance for the generation, resolution and closure of deviations
Provide Process Validation oversight as part of the Change Control process.
Generate documents (Plans, protocols and reports)
Gather data for reports or provide data verification
Represent process validation in project meetings