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Merck looking for Quality Operations Executive | M.Pharm, M.Sc, B.Pharm

 

Clinical courses

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 : Executive - Quality Operations

Job Description
• Development & implementation plan of Quality standards, QMS
• Continual review of current standards/systems/SOPs and improvement plans for Quality Management Systems (QMS) based on Global standards, & local regulations.
•  Continual review of current standards/systems/SOPs and improvement plans for Quality Management Systems (QMS) based on Global standards, & local regulations.
• Perform and Review risk analysis (e.g. process validations, rework processes, stability data, systems, etc.)
• Artwork Management in accordance with regulatory norms and pharmacopoeial changes
• Review of validation and transfer documents of new developed products coming from R&D (handover),
• Support in planning, supervising and reporting of validation, re(validation), transfers and stability / packaging materials studies, assessment of data needed to meet product compliance on a regular base
• Understanding of Change Control Management, Deviations Management, Investigation, Complaint Management, CAPA management, Audit Management, etc
• Support in technology transfer of identified products at CMO with required system and procedure, including documentation
• Support for self-inspection audits, implementation of CAPA/compliance etc.
• Support in Quality Technical Agreements.

Candidate Profile
• Graduate/Post graduate in Science or Pharmacy
• Minimum 6 years experience in Pharmaceutical Industry
• Must have worked in Quality Assurance in a pharmaceutical of repute
• Effective communication skill (written & verbal)

Additional Information
Experience : 6 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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