Job Summary - Driving critical audits in Pharmacovigilance and CSV, engagement level audits on a periodic basis, identify process non-compliances/ potential delivery failures with the objective of raising timely alerts/ risks for management intervention/ decision, providing assurance on product/service delivery within the organization norms and guidelines.
Educational Qualification
• Education: Science/Pharma/ Engineering Graduate/Post- Graduate
• Work Experience: Overall experience of 10-12 years and relevant experience 8-10 years
Responsibilities
• Audit Planning, Preparation, Execution, Finding classification, Reporting, Finding verification and Closure
• Own and conduct various types of internal audits
• Own and support external certifications for ISO audits and client audits
• Assess, identify, and provide Early Risk Alerts to delivery and leadership teams, provide recommendations to mitigate the same avoiding customer escalations.
• Develop strategic initiatives to maintain and improve the audit function which in turn adds value to the business.
• Articulate audit reports, log the same in the internal tool within the SLA period
• Review the audit findings of other auditors and mentor /upskill them as required
• Verify the CAPA taken by the team objectively and ensure closure of findings, within the SLA and ensure findings don’t become aged and obsolete
• Facilitate the project teams, Compliance teams and other teams for the external audits and customer audits by planning and executing mock assessments.
• Collaborate and work as a team, wherever applicable
• Train/Mentor new hires
• Participate in knowledge sharing sessions
• Ensure Audit readiness and execute relevant responsibilities during external audits/inspections
Meeting Audit service levels and ensure quality of Audit findings