To handle the cleaning Validation activities for Injectable manufacturing lines.
Preparation & revision of CVMP
Updating and Approval of CV Matrix.
Preparation and Review of Cleaning Validation related Checklists, Protocol and Reports and its related assessments/training (as applicable).
Implementation of new applications related to Cleaning Validation.
Provide support for troubleshooting, root cause analysis and product impact assessments for non-conformance investigations and process changes/improvements.
Support for regulatory audits.
Initiation, review and approval of Change controls, Incidents, Process comparision and risk assessment with respect to Validation / qualification activities.
Co-ordination with CFTs (i.e. Production, QA, QC) for tracking and execution and various documentation.
Training of employees.
Review change controls
Prepare, review, and approve technical protocols, reports, and product impact assessments related to product lifecycle management (LCM).
Initiate, change controls, incidents, and risk assessments related to technology transfer activities.
Support technology transfer activities for new products, scale-ups, line transfers, and site-to-site commercial batches for injectable products.
Support investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments.
Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements