Manager - Quality Assurance (Audit and Compliance)

JOB DESCRIPTION

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

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