David Hubert
Qa Associate Director @BA Sciences
Winchester, MA, US
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Jul 2018 — Present
Qa Associate Director @BA Sciences
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Implementing and maintaining Quality systems and procedures in compliance with all current FDA GMP regulations and guidance, as well as relevant ICH guidelines. Manage quality operations and compliance functions, provide expertise and direction in relation to quality initiatives.
SKILLS
Pharmaceutical IndustryQuality SystemGcpQuality ControlClinical TrialsRegulatory AffairsGmpU.s. Food and Drug Administration (Fda)GlpLaboratoryAseptic ProcessingLimsFdaSopGxpChange ControlLife SciencesCapaManagementLaboratory Information Management System (Lims)Software DocumentationQuality AssuranceRegulatory SubmissionsBiopharmaceuticalsU.s. Title 21 Cfr Part 11 RegulationStandard Operating Procedure (Sop)Corrective and Preventive Action (Capa)Lifesciences21 Cfr Part 11BiotechnologyValidationGood Laboratory Practice (Glp)
ABOUT DAVID HUBERT
Sr. Compliance Specialist, Quality Assurance; Merrimack Pharmaceuticals One year + of…
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