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Nitin Ankushrao
Qa Manager @Sandoz
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WORK HISTORY
Qa Manager @Sandoz
Hyderabad, IN
Quality project leader for assigned projects.Contributing towards management reviews to achieve the Site Key Quality Indicators (KQI).Management of quality systems, including deviations, change requests, OOX, Escalation, Audit CAPA.Driving quality system as process owner at Site.Maintaining Key Quality Indicator through management of quality systems.Collaborating with Site team for all-time inspection readiness plan and inspection management.Monitoring and management of supplier- Quality Agreement, audit management.Self-Inspection, laboratory and data integrity walkthrough.Key contributor for Remediation plan- Successfully contributed towards DLPM, Data accuracy check, Investigation, Reviewer Qualification.Acting as a SOP Manager-QA for Site.
EDUCATION
Earthinators Climate School
BSc - Bachelor of Science, Chemistry
SANGAMESHWER COLLEG SOLAPUR DIST-SOLAPUR
HSC
Bharati Vidyapeeth Solapur
SSC
Shivaji University
M.Sc., Chemistry
SKILLS
ABOUT NITIN ANKUSHRAO
Pharmaceutical Quality professional with enriched experience in Quality Management Systems with cGMP and regulatory compliance. Proven contributions in successful regulatory inspections (US, EU, MHRA, ANVISA, etc) and site quality remediation activities. Handling Quality Management Systems such as Deviation control and management, Change management, Quality risk management, CAPA management, OOS/OOT/OOE investigations and root cause analysis. Instrument calibration planning, Service level agreement with vendor.Global quality document review and assessment. Analytical method validation & transfer, Forced degradation studies- Project readiness. Stability studies, Process validation, Cleaning verification.Release of batch data, Pharmacopeial verification & compliance, Dossier review-Quality Module, Instrument Qualification & retirement, SOP updation, GMP Document handling.
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