Executive-Quality Operations

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Job Number: 4433

External Description: A career at Merck is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Job Title : Executive - Quality Operations

Location: Mumbai

Job Description:

  1. Development & implementation plan of Quality standards, QMS
  2. Continual review of current standards/systems/SOPs and improvement plans for Quality Management Systems (QMS) based on Global standards, & local regulations.
  3. Continual review of current standards/systems/SOPs and improvement plans for Quality Management Systems (QMS) based on Global standards, & local regulations.
  4. Perform and Review risk analysis (e.g. process validations, rework processes, stability data, systems, etc.)
  5. Artwork Management in accordance with regulatory norms and pharmacopoeial changes
  6. Review of validation and transfer documents of new developed products coming from R&D (handover),
  7. 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
  8. Understanding of Change Control Management, Deviations Management, Investigation, Complaint Management, CAPA management, Audit Management, etc
  9. Support in technology transfer of identified products at CMO with required system and procedure, including documentation
  10. Support for self-inspection audits, implementation of CAPA/compliance etc.
  11. Support in Quality Technical Agreements


Qualification, Experience & Skills:

  1. Graduate/Post graduate in Science or Pharmacy

  2. Minimum 6 years experience in Pharmaceutical Industry

  3. Must have worked in Quality Assurance in a pharmaceutical of repute

  4. Effective communication skill (written & verbal)


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2merck.com

Job Number: 180463

Community / Marketing Title: Executive-Quality Operations

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