Job Description

• Responsible for Planning, execution and clouser of site self inspection/internal audits.
• Responsible for monitoring of all CGXP activities at site.
• To ensure the effective implementation of the global action at site as per the defined timeline to maintain the continual improvement in the quality system.
• Responsible for coordination and management of regulatory inspections, including regulatory & other audits to ensure 'Anytime Audit Readiness'.
• Responsible for maintaining, reviewing of contract service provider documents & quality agreements of all contract service provider.
• Ensure the GMP nad GDP complinace.
• Responsible to ensure GXP computerized systems at site are in compliance with the current regulatory standarads.
• Ensure implementation of relevant quality policies , standarads and procedures for computerized systems.
• Ensure key documents of computerized systems consistently meets the required quality standarads throughout the lifecycle.
• Review and approve valdation deliverables and lifecycle documentation for computerized systems.
• Ensure the availability ofthe site CSVMP as per the quality procedure.
• To perform the gap assessment for the observations received across the sun sites, ensure the remediation & compliance as well with coordination from stakeholders.
• Ensure timely conducting of QRB & monthly review meetings.