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Opportunity for Assistant Manager / Manager - Quality Assurance in Abbott - experienced candidates only

 

Clinical courses

Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.

Post: Assistant Manager / Manager - Quality Assurance-14000004F3

Job Description
Key Duties would be:

  • Maintenance of Pharmacopoeial Compliance of Abbott products at External Manufacturers
  • Understanding of Reference standards and ensuring compliance for Abbott products
  • Support to ex-India Business
  • Support to Business teams
  • Handling FDA queries, Customer queries and complaints
  • Maintenance of Quality & Technical Agreements
  • Managing Product transfers & Analytical method transfers
  • Managing Monthly Department Reviews

Know How required:

  • Awareness of Drugs & Cosmetic Act and Rules
  • Awareness of Pharmacopoeial requirements (IP/BP/USP) & experienced in Handling Official monograph (Pharmacopoeia) changes
  • Have a minimum of 3-4 years’ experience on Secondary formulations production / Quality Control
  • Prefer to have experience in auditing manufacturing locations & Input Material vendors
  • Knowledge on ICH guidelines for stability evaluation of Drug products & Drug Substances
  • Experience on Handling product Transfers, customer queries & complaints
  • Have a knowledge on Product process Validations & Technology Transfers

Candidate Profile

  • Proficiency in English language and in Computers
  • Proficiency in Powerpoint presentations – creation and presentations
  • Shall have leadership qualities
  • Minimum Pharmacy graduate with Management
  • 12-14 years’ experience in which a minimum of 3 years shall be in production / quality control
  • Knowledge of external manufacturing Quality

Additional Information:
Experience:
12-14 yrs
Qualification:
B.Pharm, B.Sc
Location: Maharashtra-Greater Mumbai
Industry Type: Pharma / Biotech / Clinical Research
Functional Area: QA
Last Date: 15th May, 2015

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