Merck looking for Quality Operations Executive

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