Misbahul Hasan Ansari
Associate Director-i Global Qait @Viatris
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WORK HISTORY
Associate Director-i Global Qait @Viatris
Hyderabad, IN
Own governance and approval oversight for quality-impacting deliverables: change controls, incidents, investigations, CAPAs, SOPs, periodic reviews, validation documentation, and legacy remediation plans—ensuring consistent, inspection-ready outcomes.• Drive cross-site standardization of policies, procedures, and playbooks to reduce variability and strengthen QMS maturity across sites.• Establish risk-based compliance models for data integrity, reliability, and security; translate risk into practical mitigation and sustainable controls.Digital Quality / CSV–CSA / GxP IT Compliance• Lead validation and compliance governance for GMP computerized systems across lab, manufacturing, equipment/instruments (including PLC-associated systems), and enterprise platforms.• Align lifecycle controls to GAMP 5 expectations and internal SDLC/security standards; lead vendor assessment/qualification for computerized systems and service partners.• Enable capability building through training/coaching on CSV, Data Integrity, and 21 CFR Part 11 / EU Annex 11 to strengthen execution consistency across teams.Enterprise & Transformation Support• Support enterprise transformation initiatives (e.g, SAP landscape and S/4HANA planning) through compliance-by-design governance and inspection readiness alignment.
EDUCATION
Aligarh Muslim University
Master of Science (M.Sc.), Industrial Engineering
ABOUT MISBAHUL HASAN ANSARI
Quality Systems, Compliance, and Digital Quality leader with 23+ years in pharmaceutical…
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