System Assurance Specialist

6 days ago


Palakkad, Kerala, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Description

As a Validation Engineer, you will be responsible for ensuring that our products and services meet the highest standards of quality and compliance. You will work closely with cross-functional teams to develop and implement validation strategies that align with regulatory requirements.

Your primary focus will be on computer system validation, quality compliance, and process validation. You will have hands-on experience in EDMS and Test Management tools, as well as a strong understanding of FDA and ISO regulations.

You will also be responsible for developing clear and concise reports, working on complex projects with minimal guidance, and managing priorities and workflow effectively.

Required Skills and Qualifications
  • Bachelor's degree in a related field or equivalent.
  • 5-8 years of hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP systems.
  • Strong knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Hands-on experience in EDMS and Test Management tools.
  • Understanding of FDA's recent guidance on transition of CSV to CSA.
Benefits

This is an excellent opportunity to join a global organization with a diverse workforce and a commitment to innovation and excellence. You will have the chance to work on complex projects, develop your skills and expertise, and contribute to the success of the company.

Others

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.



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