Validation Expert

21 hours ago

Jodhpur, Rajasthan, India beBeeValidation Full time ₹ 15,00,000 - ₹ 25,00,000

Job Title: Validation Expert

Job Description:

People Prime Worldwide's client is seeking a highly skilled validation expert to support their operations in Jodhpur. The ideal candidate will have extensive experience in computer system validation and quality compliance within FDA-regulated industries.

Required Skills and Qualifications:
  • Mandatory skills include 5-8 years of hands-on experience in computer system validation/quality compliance with a focus on GxP systems, fundamental cGMP concepts, and FDA/EMA regulations.
  • Strong knowledge of FDA regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Experience with EDMS (Electronic Document Management system) & Test Management tools.
  • Understanding of FDA's recent guidance on transition of CSV to CSA.
  • Ability to develop clear, concise, and timely oral and written reports with excellent written and oral communication skills.
  • Ability to work on complex projects with general direction and minimal guidance, handle multiple projects, and meet deadlines.
  • Ability to manage priorities and workflow with versatility, flexibility, and a willingness to work within constantly changing priorities.
Benefits:

The ideal candidate will be part of a dynamic team working on challenging projects with opportunities for growth and development.

Key Responsibilities:

  • Develop and implement effective validation strategies and procedures.
  • Collaborate with cross-functional teams to ensure seamless integration of validated systems.
  • Conduct thorough risk assessments and identify areas for improvement.
  • Provide technical guidance and training to team members.
  • Stay up-to-date with industry regulations and best practices.

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