System Validation Specialist

2 days ago

Aurangabad, Maharashtra, India beBeeComputer Full time ₹ 80,00,000 - ₹ 1,35,00,000

At People Prime Worldwide, we are dedicated to delivering high-quality solutions to our clients in the medical device and pharmaceutical industries.

About the Role

This position plays a vital role in ensuring the quality and compliance of our clients' products. As a Computer System Validation Engineer, you will be responsible for validating computer systems and equipment, as well as developing clear and concise reports to communicate your findings.

  • Bachelor's degree in a related field or equivalent is required.
  • A minimum of 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 is necessary.
  • Strong knowledge of FDA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards is essential.
Key Responsibilities
  • Develop and execute validation plans for computer systems and equipment.
  • Conduct risk assessments and develop mitigation strategies.
  • Collaborate with cross-functional teams to ensure seamless execution of projects.
  • Provide timely and accurate reporting to stakeholders.

This role requires strong analytical and problem-solving skills, as well as excellent written and oral communication skills. If you have a passion for ensuring the highest level of quality and compliance, we encourage you to apply for this exciting opportunity.

Requirements
  • Bachelor's degree in a related field or equivalent is required.
  • A minimum of 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 is necessary.
  • Strong knowledge of FDA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards is essential.

As a team member at People Prime Worldwide, you will have opportunities for growth and development, as well as a competitive compensation package.

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