Review and closure, of QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation).
QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation) KPI data maintenance.
QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation) Trend Analysis Report preparation review and approval as per the schedule.
QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation) PQR preparation, review and approval as per the schedule QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation).
QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation) audit lists preparation, review and approval as and when required.
Monthly MRM review for QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation).
Ensuring QMS audit readiness. Establish and maintain the global quality system standards for Biologics manufacturing site.
Drive Continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements.
Managing QMS team and ensuring regular working of QMS team members.
Monitoring of GxP in manufacturing and quality control followed by escalation of gaps associated with the practices on data.
To Adhere to the Good hygiene practices and reporting to illness and other unhygienic incidents.
To ensure Current Good Manufacturing, Practices GDP are followed in all documents during review, approval and closure any other additional responsibility assigned by Reporting Manager.
Key Responsibilities
Review and closure, of QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation).
QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation) KPI data maintenance.
QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation) Trend Analysis Report preparation review and approval as per the schedule.
QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation) PQR preparation, review and approval as per the schedule QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation).
QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation) audit lists preparation, review and approval as and when required.
Monthly MRM review for QMS elements (Event/OOS/OOT/OOAC/CAPA/Market complaint/Recall/Deviation).
Ensuring QMS audit readiness. Establish and maintain the global quality system standards for Biologics manufacturing site.
Drive Continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements.
Managing QMS team and ensuring regular working of QMS team members.
Monitoring of GxP in manufacturing and quality control followed by escalation of gaps associated with the practices on data.
To Adhere to the Good hygiene practices and reporting to illness and other unhygienic incidents.
To ensure Current Good Manufacturing, Practices GDP are followed in all documents during review, approval and closure any other additional responsibility assigned by Reporting Manager.