Mbacke

About Mbacke

Senior Consultant• Led various projects for clients including AMGEN, Pfizer, Zimmer Biomet, Sanofi Pasteur, Cognate BioServices, Piramal Pharma Solutions, Valeant Pharmaceuticals, HOSPIRA, Medimmune/AstraZeneca, Inc, Celsis InVitro Technologies and other established and start-up Bio and Pharma companies.• 23 years of extensive experience with QA compliance, investigations, training QC/QA, auditing and managing all non-compliance issues and creating documents/reports using document control system. Also reviewed / approved compliant investigation reports and annual product documentation. • Equipment Validation including but not limited to cleaning, sterilization and manual cleaning validation.• FDA device/drug/biologics regulations.• Conducted internal site and external CMOs audits as needed.• Excellent experience with various regulations like cGMP and 21 CFR Parts 210, 211, GCP, ISO, GLP, QSR and TrackWise, SharePoint, SharePoint Cloud, SoftMax, MRP/ERP and LIMS.• Worked with various computer systems for quality applications like - CAPA LIMS, MS Office etc• Led the plant CAPA program and initiative using - Trackwise. • Work well in a fast paced small / medium company environment.• Excellent team player. Works well with contract manufacturers, suppliers and production personnel, etc.• Experience with lab equipment qualification (IQ, OQ, PQ) protocol review and writing.• Hand-on skills on Environmental Monitoring Program in Aseptic manufacturing such as air viable & non-viable, surface monitoring, TOC, Bioburden, LAL, Conductivity, media growth promotion and bacteria identification system using vitek system. • Fluent in French.• Internal audit, Product release, Batch record review, equipment validation, calibration, Environmental monitoring, Utilities (WFI, Clean Supply Water and DI Water) response. Change Control, Investigation of Product Complaints and Implementation of effective CAPA, Annual Product Quality Review (APQR), Gap Assessment and Remediation of Quality Systems, FDA 483 Observations

Experience

1. Qa Sme Consultant

   Immunomedics

   Oct 2019 — Present · Morris Plains, NJ, US

Skills

• Vaccines
• Biochemistry
• Quality Control
• Gmp
• Corrective and Preventive Action (Capa)
• Pharmaceutical Industry
• Sop
• Fda
• Life Sciences
• Lifesciences
• Good Laboratory Practice (Glp)
• Elisa
• Microbiology
• Validation
• Quality System
• Molecular Biology
• Protein Chemistry
• Change Control
• Cell
• Glp
• Quality Assurance
• Research
• Analytical Chemistry
• Compliance Management
• Biotechnology
• Oncology
• Capa
• U.s. Food and Drug Administration (Fda)
• Hplc
• Chromatography