Job Description

u2022 Conduct audits of Raw and Packaging Materials vendors, including that of active material vendors of Abbott, EPD, India u2022 May also conduct audits of Third Party manufacturers manufacturing / supplying products to Abbott, EPD, India u2022 Conduct internal audit program for Abbott EPD India. u2022 Organize annual audit schedule along with the team and ensure execution. u2022 Stay aligned to functional policy, procedure and regulatory guidelines. Ensure compliance to organizational policies and procedures for functional areas. u2022 Review and ensure applicable SOPs are in place as per requirement. u2022 Conduct due-diligence audits of potential new contract manufacturing sites. u2022 Conduct u201CFor Causeu201D audits to investigate quality issues and significant events. u2022 Identify and report Quality and Compliance risks, gaps arising from audits. u2022 Ensuring audit reports issued on time as per approved SOP timelines u2022 Review audit compliance response, track CAPAs and ensure audit closure. u2022 Guide contract manufacturing sites for quality compliance and improvements. u2022 Plan, prepare and execute compliance and improvement projects. u2022 Update department lead, CFTs on audit summary, trend, concerns from audit & compliance. Ensure availability of summary data every month for area management reviews u2022 Collaborate with key stakeholders to facilitate business processes. u2022 Ensure AudiQ system is implemented for audit documentation. u2022 Monitor and continuously improve performance metric for Audit function.

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