Job Scope:
- The entire operational aspects to established SOP, GMP, GDP and GLP practices and regulatory requirements.
- Handling issues from cross functional departments like QC/ Production/ Warehouse/ Engineering etc.
- Ensure procedures and practices are adhered in accordance with cGMP requirements.
- Conducting Risk Assessment, collect sample during validation process and qualification.
- Involve and provide expertise in vendor audit, evaluation/qualification and assessment and ensure proper execution of validation (IQ, OQ, PQ etc.).
- Advisory on Corrective and Preventive Action (CAPA) arisen out of External/Internal audits, Unusual Occurrences/Incidents, Failures and Market complaints.
- Advisory on documentation and management of deviations, critical process steps parameters.
