Peniel Ortega
Managing Director @Pharmallies
Raleigh-Durham-Chapel Hill, NC, US
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Jan 2014 — Present
Managing Director @Pharmallies
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SKILLS
BiopharmaceuticalsR&DQuality AuditingTechnology TransferQuality AssuranceAseptic ProcessingGmpCorrective and Preventive Action (Capa)Verification and Validation (V&V)Standard Operating Procedure (Sop)CapaQuality SystemV&VGxpCleaning ValidationSopMedical DevicesGlpProcess SimulationPharmaceutical IndustryRegulatory Affairs21 Cfr Part 11U.s. Food and Drug Administration (Fda)GampValidationQuality ControlRoot Cause AnalysisChange ControlIso 13485FdaComputer System ValidationU.s. Title 21 Cfr Part 11 RegulationDecommissioningGood Laboratory Practice (Glp)Regulatory RequirementsBiotechnology
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