Computer System Validation Specialist

10 hours ago

Kolkata, West Bengal, India beBeeComputerSystemValidation Full time US$ 1,00,000 - US$ 1,40,000
System Validation Specialist

Our client is a leading provider of technology and consulting services to clients across the globe. With a presence in 60+ countries, they deliver end-to-end solutions that meet the evolving needs of their customers.

Job Title: System Validation Engineer
Location: Bengaluru, Hyderabad
Experience: 5+ years
Job Type: Full Time Permanent

Notice Period: Immediate joiners

Client: MNC Client

Mandatory Skill: Computer System Validation, EDMS, Medical Domain

Required Skills and Qualifications:

  • Bachelor's degree (B.S.) in a related field or equivalent.
  • 5-8 years hands-on experience in system validation with a focus on GxP systems.
  • Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Strong knowledge of manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Hands-on experience in EDMS and test management tools.
  • Understanding of recent guidance on CSV to CSA transition.
  • 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.

Benefits:

The role offers an exciting opportunity to be part of a dynamic team and contribute to the growth and success of the organization. As a system validation specialist, you will have the chance to work on complex projects, develop your skills, and advance your career.

Other Opportunities:

As a valued member of our team, you will have access to training and development opportunities, mentorship programs, and networking events. You will also have the chance to collaborate with experts from around the world and contribute to innovative solutions that make a real impact.

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