DEx – Lifescience (Pharmacovigilance) – Manager

Location: Pune, Chennai, Delhi, Bangalore, Kolkata, Hyderabad, Mumbai, Bhubaneswar, Gurgaon, Coimbatore, Noida, Kochi, Mesaieed   •   Experience: Senior Level   •   Openings: 1
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Job description

Audit Planning, Preparation, Execution, Finding classification, Reporting, Finding verification and Closure
Own and conduct various types of internal 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
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.
Train/Mentor new hires
Ensure Audit readiness and execute relevant responsibilities during external audits/inspections
 
Must Have Skill Set
Pharmacovigilance
Quality Audit
Internal and External Audit