System Quality Assurance Specialist

2 weeks ago

Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Validation Engineer

About Us:

We are a global technology company providing IT, consulting and business process services. Our expertise includes cloud computing, security, digital transformation, artificial intelligence, robotics, data analytics and other technologies.

  • Job Title : Validation Engineer
  • Experience : 5-10 Yrs
  • Employment Type : Full time

Mandatory Skills:

  • Computer System Validation/Quality Compliance in FDA Regulated industry (Medical Device/Pharma/Life Sciences) with focus on GxP system.
  • Fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, ISO 9001 Standards.
  • FDA Regulated manufacturing processes, process validation, computer and equipment validation, GMPs.
  • EDMS (Electronic Document Management system), Test Management tools.
  • FDA's guidance on transition of CSV to CSA.
  • Clear, concise, timely oral and written reports. Excellent written and oral communication skills.
  • Complex projects with general direction and minimal guidance.
  • Multiple projects, meet deadlines. Manage priorities and workflow. Versatility, flexibility, willingness to work within changing priorities.

As a skilled Validation Engineer, you will play a key role in ensuring the quality and compliance of our products. Your responsibilities will include validating computer systems, documenting processes and procedures, and maintaining accurate records.

Join us and take your career to the next level by working with a dynamic team that is passionate about delivering high-quality results.

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