Expert Validation Specialist

1 day ago

Jaipur, Rajasthan, India beBeeValidation Full time ₹ 18,00,000 - ₹ 24,00,000

Job Summary

We are seeking a skilled professional to fill the role of Validation Specialist. This position requires strong analytical and problem-solving skills, excellent communication skills, and the ability to work effectively in a team environment.

About the Position

This challenging project involves working on complex systems and processes. The ideal candidate will possess a deep understanding of FDA regulations and guidelines, including cGMP concepts and ISO 9001 Standards.

  • Develop and implement system validation plans to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to design and test software applications.
  • Analyze and troubleshoot technical issues to ensure timely resolution.
  • Communicate complex technical information to both technical and non-technical stakeholders.

Qualifications

Requirements include:

  • 5-8 years hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
  • Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Hands-on experience in 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. 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.

Benefits

Our company offers a dynamic and growth-oriented work environment where you can advance your career and develop new skills.

How to Apply

To be considered for this opportunity, please submit your application with your resume and cover letter.

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