Carmen Umbarita

Senior Manager R & d Qa @Teva Pharmaceuticals

Fort Lauderdale, FL, US
EMAILS
c••••••••@tevapharm.com
MOBILE NUMBERS
+17•••••••47

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WORK HISTORY

Mar 1997 — Present

Senior Manager R & d Qa @Teva Pharmaceuticals

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Weston, FL, US

EDUCATION

2003 — 2005

University of Phoenix

Bachelors in Science Business Management, Business Management

2000 — 2004

Broward College

Business, Management, Marketing, and Related Support Services

SKILLS

GampManufacturingR&DMedical DevicesCapaGlpCqaQuality ManagementSpcBiopharmaceuticalsIso 13485Quality AssuranceComputer System ValidationIsoPharmaceutical IndustrySopFdaQuality SystemV&VRegulatory SubmissionsDocument ManagementProcess SimulationDesign ControlLeadershipAuditingHplcTechnology TransferTrainingRegulatory RequirementsAnalytical ChemistryValidationFda GmpLimsTrackwiseIso 14971Regulatory AffairsGxpQuality AuditingAseptic ProcessingSupply Chain

ABOUT CARMEN UMBARITA

Quality Assurance Leader with over 30 years of experience in the Pharmaceutical Industry. Expertise in Oral Solid Dosage, Veterinary and Transdermal Pharmaceuticals. Highly skilled professional with extensive knowledge and background in fields such as Change Management, Compliance, Manufacturing/Packaging Operations, Quality Management Systems, Supply Chain and Logistics, Vendor Management, Investigations/CAPAs and Federal and International Regulatory Inspections. Experience in the development, revision and approval of SOP’s, analytical testing methods, product specifications, protocols, product validations and equipment (IQ/OQ/PQ) qualifications. Adaptable and able to work independently or as a team in a fast-paced environment with limited or no supervision. Able to consistently maintain high levels of productivity.

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