Senior Officer

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.