Personal Information
Entreprise/Lieu de travail
Gwalior Area, India India
Profession
Deputy Manager - Quality Assurance at Alere Inc.
Secteur d’activité
Medical / Health Care / Pharmaceuticals
À propos
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: