Chief Validation Specialist

4 days ago

Palakkad, Kerala, India beBeeValidation Full time ₹ 15,00,000 - ₹ 24,00,000

Job Overview

A highly skilled Validation Engineer is required to ensure the quality and integrity of our systems. As a key member of our team, you will be responsible for validating computer systems to meet regulatory requirements.

Key Responsibilities
  • Mandatory Skills:
  • At least 5-8 years of 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.
  • Fundamental knowledge of cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • 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.

We are seeking a detail-oriented individual who can provide expertise in computer system validation and quality compliance. The ideal candidate will have hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry with a focus on GxP system. They will also have strong knowledge of fundamental cGMP concepts and FDA/EMA regulations.

Benefits:

  • Opportunity to work on complex projects.
  • Chance to develop expertise in computer system validation and quality compliance.
  • Excellent opportunity for career growth and professional development.

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