Our businesses in U.S. and Canada operate as EMD Serono in Biopharma, MilliporeSigma in life science and EMD Performance Materials in the chemicals and high-tech materials business. Outside of the U.S. and Canada, we hold the rights to the name and the trademark “MERCK”. The businesses of Merck KGaA, Darmstadt, Germany are truly global, with 52,000 employees in 66 countries working on breakthrough solutions and technology.
Post : Assistant Manager - Quality Operations
Job Description
• Management of the Market complaints, Change controls, Validation systems, deviations, incidents, CAPAs.
• Carrying out Quality risk assessment wherever necessary.
• Update all Quality tracking systems in TW for Market complaints regularly.
• Keeping track on central warehousing and distribution activities of Export products.
• Support for liaison with New Product Introduction / Technology Transfer.
• Support for maintenance of all quality documents from various Vendors, CMO, etc.
• Support for maintenance of product consistency at all CMOs for manufacturing & Analysis.
• Support for managing the QA operations for the Merck Ltd. – One Healthcare, India
• Continual review of current Quality policies and improvement plans for the Quality Management Systems (QMS) based on global document management systems.
• Support for developments of Vendor, CMO, Central Warehouse audit schedules.
• Support for developing annual audit schedule based on risk, frequency and quality experience.
• Support for additional assigned task i.e. Analytical method development and process optimization as per requirement and given timeline.
Candidate Profile
• Graduate/Post graduate in Science or Pharmacy
• Minimum 10 years experience in Pharmaceutical Industry
• Must have worked in Quality Assurance in a pharmaceutical of repute
• Effective communication skill (written & verbal)
Additional Information
Experience : 10 years
Qualification : M.Pharm, M.Sc, B.Pharm, B.Sc
Location : Mumbai, Maharashtra
Industry Type : Pharma
Functional Area : Quality Operations
End Date : 15th September, 2018
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