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WILNER A

General - 7 Years of Experience

Occupation:

General

Education Level:

Bachelor

Will Relocate:

YES

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KEY QUALIFICATIONS: * COMPLAINTS & TECHNICAL SUPPORT SPECIALIST WITH 5+ YEARS OF PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRY experience * 5+ years of experience with product complaints including experience with Global Customer Complaints (GCC), adverse events, and auditing of complaint records * Excellent knowledge of quality standards and regulations: FDA QSR 21 CFR 803 & 820, ISO Standards 9001 / 13485 / 14971, MDD 93/42/EEC and SOR/98-282 and Pharmacovigilance * Experience ensuring compliance with GMP, GCP, GLP, ICH and MedDRA Coding * Solid organization and customer service skills with strong verbal, written and analytical communication skills * Fluent in English, French, and Spanish

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