Quality Compliance Specialist

23 hours ago


Dindigul, Tamil Nadu, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000
Job Title: Quality Compliance Specialist

About Our Role:

We seek a seasoned Quality Compliance Specialist to join our team. In this critical position, you will be responsible for ensuring the quality and integrity of our systems and processes.

  • Key Responsibilities:
  • Lead computer system validation efforts in a regulated industry, focusing on GxP systems.
  • Familiarize yourself with fundamental cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Develop strong knowledge of FDA-regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Gain hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
  • Stay up-to-date with recent FDA guidance on CSV to CSA transition.
  • Produce clear, concise, and timely oral and written reports. Demonstrate excellent written and oral communication skills.
  • Work effectively on complex projects with general direction and minimal guidance.
  • Manage multiple projects, meet deadlines, prioritize tasks, and adapt to changing priorities.


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