Kuldeep Yagik

Gwalior Area, India India

Deputy Manager - Quality Assurance at Alere Inc.

Medical / Health Care / Pharmaceuticals

Professional Summary: • A competent professional with dynamic experience of 09 years 06 months in the function of Quality Assurance & Microbiology Department and year-on-year success • Working experience in GxP regulated Industry, in Quality Compliance function with knowledge of cGMP, 21CFR part 210,211 & 820 Quality System Regulations, ISO 9001 & ISO 13485 QMS. • Functionally expertise in handling the quality operations in sterile drug manufacturing facility (sterile formulations in SVP & LVP in forms of liquid & dry Injection glass vials & FFS and sterile API) • Experience of regulatory inspections: WHO-Geneva, USFDA, UKMHRA, TGA & ANVISA. Skills: • Quality Management System: