Senior Software Validation Specialist

2 days ago

Rajkot, Gujarat, India beBeeComputerSystemValidation Full time ₹ 10,00,000 - ₹ 15,00,000
Computer System Validation Role

People Prime Worldwide is seeking a skilled Computer System Validation professional to join their team.

About the Position:

  • Validating computer systems to ensure compliance with regulatory requirements.
  • Collaborating with cross-functional teams to develop and implement validation strategies.
  • Conducting risk assessments and developing mitigation plans to address potential issues.
  • Communicating effectively with stakeholders to provide timely and accurate updates on validation progress.

Key Qualifications:

  • Bachelor's degree in a related field, such as computer science or engineering.
  • 5-8 years of hands-on experience in computer system validation, quality compliance, and FDA regulated industries.
  • Fundamental knowledge of cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 standards.
  • Strong understanding of FDA regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Experience with EDMS (Electronic Document Management system) & Test Management tools.
  • Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills.
  • Ability to work on complex projects with general direction and minimal guidance.
  • Ability to handle multiple projects and meet deadlines.
  • Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.

Working at People Prime Worldwide:

At People Prime Worldwide, we value innovation, teamwork, and customer satisfaction. We strive to create an inclusive work environment that fosters growth, development, and success for all employees. If you are passionate about computer system validation and committed to excellence, we encourage you to apply for this exciting opportunity.

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