Computer Systems Quality Assurance Specialist

4 days ago

Nashik, Maharashtra, India beBeeValidator Full time ₹ 12,05,000 - ₹ 20,99,800

System validation is a critical process in the software industry, ensuring the integrity and quality of computer systems. As a system validator at a leading global player, you will be responsible for developing and executing test plans to validate computer systems against GxP regulations such as cGMP, FDA/EMA, QSR, and ISO 9001 Standards.

The role requires collaboration with cross-functional teams to identify and address system validation gaps and deviations. Designing and implementing electronic document management systems (EDMS) and test management tools are also essential aspects of this position.

To excel in this role, you will need to conduct process validation, computer and equipment validation, and GMP audits to ensure compliance. Strong knowledge of fundamental cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards is required.

A bachelor's degree in a related field or equivalent is necessary, along with 5-8 years of experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences). Ability to develop clear, concise, and timely oral and written reports is also crucial.

This position offers opportunities for growth and development in a dynamic and collaborative environment. A fast-paced global software giant with a strong emphasis on quality and innovation provides a challenging work environment.

Key Responsibilities:

  • Develop and execute test plans to validate computer systems against GxP regulations
  • Collaborate with cross-functional teams to identify and address system validation gaps and deviations
  • Design and implement electronic document management systems (EDMS) and test management tools
  • Conduct process validation, computer and equipment validation, and GMP audits to ensure compliance

Requirements:

  • Bachelor's degree in a related field or equivalent
  • 5-8 years of experience in Computer System Validation/Quality Compliance in a FDA Regulated industry
  • Strong knowledge of fundamental cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards
  • Ability to develop clear, concise, and timely oral and written reports

Working Environment:

  • Fast-paced global software giant with a strong emphasis on quality and innovation
  • Opportunities for growth and development in a dynamic and collaborative environment

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