Computer System Integrity Specialist

3 days ago

Alwar, Rajasthan, India beBeeSystemValidator Full time US$ 1,60,000 - US$ 2,20,000

Role Summary:

We are seeking an experienced Computer System Validation Professional to join our team.

The ideal candidate will have a strong background in Computer System Validation, with a focus on GxP systems and FDA regulations.

Job Description

This is a challenging role that requires excellent analytical and problem-solving skills.

The successful candidate will be responsible for ensuring the integrity and compliance of computerized systems used in the development, testing, and delivery of medical devices and pharmaceuticals.

Responsibilities include:

  • Designing and implementing system validation protocols and procedures
  • Conducting risk assessments and audits to identify potential vulnerabilities
  • Developing and maintaining technical documentation and reports

Required Skills and Qualifications:

  • Bachelor's degree in a related field (e.g., Computer Science, Engineering, Biology)
  • 5+ years of experience in Computer System Validation, with a focus on GxP systems and FDA regulations
  • Knowledge of cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 standards
  • Strong analytical and problem-solving skills
  • Excellent written and verbal communication skills
  • Able to work independently and as part of a team

Benefits:

This is a full-time permanent position with a competitive salary and benefits package.

Our company values work-life balance and offers flexible working arrangements.

Join our dynamic team and contribute to the success of our organization.

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