David Beroll

Principal Consultant @CAI

Austin, TX, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2020 — Present

Principal Consultant @CAI

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TX, US

EDUCATION

1986 — 1990

University of Massachusetts Amherst

BSME, Mechanical Engineering

SKILLS

Change ControlSix SigmaGxpEquipment QualificationQuality AuditingAseptic ProcessingPharmaceuticsIso 14971Quality AssuranceDesign ControlSterilizationRegulatory AffairsLifesciencesAnalytical ChemistryCleaning ValidationTrackwiseManufacturingCgmp PracticesCalibrationGlpBiopharmaceuticalsChromatographyCgmp ManufacturingQuality SystemIsoPharmaceutical IndustrySopFdaDocument ManagementProcess SimulationValidationDeviationsTechnology Transfer21 Cfr Part 11Root Cause AnalysisR&DEngineeringQuality ControlGmpGamp

ABOUT DAVID BEROLL

Validation, Quality Assurance, Process, Project, Equipment and CommissioningEngineering Professional over 25 years of industry experience in:Pharmaceuticals, BioPharmaceuticals, Combination Products and Medical Deviceswth a knowledge and understanding to apply- Current drug and medical device regulations from the FDA and foreign regulatory bodies - Industry guidelines and standards including ISPE, PDA, ASME, ISO and ANSI - US and Foreign Pharmacopeial specifications and methodsand the ability to- Effectively and efficiently communicate and present ideas, opinions and findings orally and in writing - Successfully interact with all levels of management, professionals, vendors, contractors and tradespeople - Use a structured approach (RCA) to identify issues, actual or potential problems and adverse events - Determine, document and apply corrective and preventative actions (CAPA)- Self-manage time and tasks to maximize productivity and meet or exceed goals and deadlines

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