System Assurance Specialist

3 days ago


Kolkata, West Bengal, India beBeeAssurance Full time ₹ 70,00,000 - ₹ 1,25,00,000

System Assurance Specialist

About this critical role:

The System Assurance Specialist plays a key part in ensuring the quality and compliance of our systems.

Key Responsibilities:

  • Develop and implement assurance plans for computer systems and equipment to guarantee high-quality performance and reliability
  • Ensure adherence to regulatory requirements, including FDA guidelines and international standards such as GxP system requirements
  • Manage electronic documentation and test management tools effectively
  • Collaborate with cross-functional teams to achieve project objectives and deliverables

Requirements:

  • Bachelor's degree in a relevant field or equivalent academic background
  • 5-8 years of experience in System Assurance/Quality Compliance in a regulated industry, preferably within the FDA-regulated sector
  • Strong knowledge of FDA regulations, QSR, 21 CFR Part 820, and ISO 9001 Standards
  • Excellent written and oral communication skills

Preferred Skills:

  • Hands-on experience with Microsoft Office and Visio


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