Quality Assurance Professional

2 days ago

Tiruppur, Tamil Nadu, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

About People Prime Worldwide:

We are a global software giant with over 11.3 billion dollars in revenue, a workforce of 240,000 employees, and operations in 60+ countries.

As a Validation Engineer at our company, you will play a key role in ensuring the quality and compliance of our systems.

Key Responsibilities:

  • Develop and maintain computer system validation plans and reports
  • Ensure compliance with FDA regulations, including cGMP concepts, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards
  • Collaborate with cross-functional teams to implement process validation and GMPs
  • Utilize EDMS and Test Management tools to manage documents and tests

Requirements:

  • Bachelor's degree in a related field or equivalent
  • 5-8 years of experience in Computer System Validation/Quality Compliance in a FDA Regulated industry
  • Strong knowledge of fundamental cGMP concepts and FDA/EMA regulations
  • Excellent written and oral communication skills

Preferred Skills:

  • Hands-on experience with Microsoft Office and Visio
  • Knowledge of FDA's recent guidance on transition of CSV to CSA

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