Corporate Office|Corp. Office, Ahmedabad, Gujarat, India
12 - 15 Years
Job Description
Job Responsibilities
- 1. To follow SOP on" CentralQuality - Audit and Compliance".
- 2. To follow CACmonthly schedule for audit execution activity at identified sites and supportfunctions.
- 3. To plan &execute; additional audits/review based on management need and guidance.
- 4. To prepare andreview audit agenda based on site performance and expected regulatoryinspection at site.
- 5. To ensure executionof Corporate Quality Audit for quality systems as per SOP.
- 6. Participate inaudit opening and closing meetings. To discuss audit observations with siteleadership.
- 7. To ensureholistic compliance need/expectations for the CAC/Regulatory/GMP consultantaudit findings.
- 8. Apprise the auditoutcome to Head Technical Services, Head Central Quality and Head CAC priorto submit final report.
- 9. To categorizecitations and submission of final report in Audit portal as per SOP
- 10. To prepareexecutive summary of audit for management escalation.
- 11.



Timelysubmission of audit reports and review response to audit observations as perSOP.
- 12. To ensure complianceverification of identified CAC/External SME/regulatory CAPA for adequacyduring periodic or verification audits and off-site review, as applicable.Report compliance status during periodic departmental & managementreview.
- 13. To assist sitefor readiness during regulatory or GMP consultant inspections, as needed.
- 14. To review thedraft response for adequacy prior to submission to regulatory/SME agency.
- 15. Preparationofcompliance reports periodically for the respective sites for managementreview.
- 16. To participate inthe departmental and management review meetings for escalation of specificissue for compliance and support.
- 17. To participate inCentral Quality Policy preparation, review and implementation.
- 18. Update self with current regulatory guidance/GMP trends, current industryknowledge regarding the system and pro

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