Certified Validation Specialist

4 days ago

Vijayawada, Andhra Pradesh, India beBeeValidationEngineer Full time ₹ 1,51,72,642 - ₹ 2,19,09,358
Job Overview">

The role of a Validation Engineer is critical in ensuring the quality and reliability of systems and processes within a regulated environment.

Our client, a leading Indian multinational technology company, seeks an experienced Validation Engineer to join their team.

  • Experience: 5-10 years
  • Employment Type: Full-time
Key Responsibilities">

As a Validation Engineer, your key responsibilities will include:

  • Developing and implementing computer system validation strategies for FDA-regulated industries.
  • Conducting risk assessments and gap analyses to identify areas for improvement.
  • Creating and maintaining documentation, including test plans, scripts, and reports.
  • Collaborating with cross-functional teams to ensure seamless implementation of validated systems.
  • Providing training and support to end-users on validated systems.
Required Skills and Qualifications">

To be successful in this role, you will need:

  • Hands-on experience in Computer System Validation/Quality Compliance in a FDA-regulated industry.
  • Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Strong understanding of EDMS and Test Management tools.
  • Excellent communication and interpersonal skills.
Benefits">

This role offers:

  • Opportunities for growth and professional development.
  • A dynamic and supportive work environment.
  • Competitive compensation package.

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