Ajay Mallesha
Associate Director -Quality Assurance
- Role
- Associate Director Quality Assurance at AstraZeneca
- Location
- Frederick, MD, US
- LinkedIn followers
- 500 followers
About Ajay Mallesha
Results driven QA/QC professional with extensive experience and expertise in ensuring compliance and quality excellence within the dynamic landscape of pharmaceutical and biopharmaceutical manufacturing (upstream, downstream, central services, W&D, supplychain & logistics, etc). Proven track record in implementing robust quality systems, successful regulatory inspections and optimizing processes to meet highest industry standards.Key Competencies/Skills:Quality Assurance/Quality Systems: Non Conformances/InvestigationsChange ManagementRisk Management/Risk MitigationAudits/Inspections (Regulatory/Client)cGMP ComplianceTrend managementGAP AssessmentsCAPA managementQuality management reviewFunctional business reviewQuality Control: Method Development/Validation/Tech TransferAnalytical/Raw material testingMicrobiology TestingEnvironmental/Utility/RTS monitoring/investigationsMethod performance trendingManufacturing operations:Process Optimization/ValidationQuality oversight/strategies to improve operational efficienciesShutdown/Return to Service supportPeople Management:Training, Guidance, Development and EmpowermentLean principlesContinuous ImprovementFoster collaborative environmentPerformance ManagementDiversity and Inclusion
Experience
Associate Director Quality Assurance
Oct 2024 — Present · US
Education
Governors State University
Master's Degree, Analytical Chemistry
2005 — 2007
Saraswathi Vidya Bhavan's College of Pharmacy
Bachelor's Degree, Pharmaceutical Sciences
2000 — 2004
Skills
- Wet Chemistry
- Quality System
- V&V
- Standard Operating Procedure (Sop)
- Analytical Method Validation
- Protocol Experience
- Cleaning Validation
- Validation
- Annual Product Review
- Reports
- Pharmaceutical Industry
- Sop
- Fda
- Drug Delivery
- Ftir
- R&D
- Capa
- Method Development
- Glp
- Stability Studies
- Gas Chromatography
- Hplc
- Quality Assurance
- Change Control
- Dissolution
- Pre-Formulation Studies
- Formulation
- Method Transfer
- Quality Control
- Gmp
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