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Senior Auditor GMP

Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

Areas of Responsibility Conducts GMP and Quality system audits primarily at Third party contractors or suppliers as lead or supportive auditor to monitor that all aspects of the operational business comply with GMP legal and regulatory requirements and the Novartis Group Quality Manual and Policies Monitors that Corrective and Preventive Actions which are necessary due the audit findings are implemented appropriately and as per schedule Evaluates and trend audit and inspection findings Maintains audit data in a related data system (incl. reports and follow-up of audits) Supports of training sessions, audit planning and risk assessments (e.g. for supplier qualification) Participate sin Due Diligence as deemed necessary Participates in Global/ Regional Audit Team continuous improvement initiatives. Conducts audits in accordance with company standard operating procedures and quality policies Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations Exercises judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance Appropriately escalates any compliance issues Communicates audit results to management and auditees through written audit reports---------------------------------- May manage post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts May assist with hosting regulatory facility inspections by acting as a scribe and/or document reviewer May draft and issue periodic reports to site management as requested May assist with training/orientation of new Quality Auditing staff May assist in providing compliance feedback to processes/procedures in regards to BD&L .
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science)

Experience: 10-15


Quality Assurance | Quality Control | Quality Inspection | Statistical Quality Control
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