System Validation Engineer

6 days ago

Tiruchi, Tamil Nadu, India beBeevalidation Full time ₹ 18,00,000 - ₹ 22,00,000

About this role:

We are seeking a highly skilled Validation Specialist to join our team.

The ideal candidate will have a strong background in Computer System Validation/Quality Compliance and a proven track record of ensuring the integrity of GxP systems.

This is an excellent opportunity for someone who wants to make a meaningful contribution to a dynamic and growing organization.

Key Responsibilities:

  • Develop and implement effective validation strategies to ensure compliance with regulatory requirements.
  • Conduct thorough risk assessments and develop mitigation plans to address potential issues.
  • Collaborate with cross-functional teams to ensure seamless execution of validation projects.
  • Maintain accurate records and documentation to support audit trails.

Required Skills and Qualifications:

To be successful in this role, you will need:

  • A Bachelor's degree in a related field (e.g., life sciences, engineering).
  • 5-8 years of experience in Computer System Validation/Quality Compliance, preferably in a FDA-regulated industry.
  • Strong knowledge of GxP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Hands-on experience with EDMS and Test Management tools.
  • Excellent communication and interpersonal skills.

Benefits:

We offer a competitive salary and benefits package, including:

  • Opportunities for professional growth and development.
  • A collaborative and dynamic work environment.
  • A comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.

Others:

We are committed to diversity, equity, and inclusion in the workplace. We welcome applications from qualified candidates who share our values and commitment to excellence.

Please note that we do not discriminate based on race, color, religion, sex, national origin, age, disability, or any other protected characteristic.

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