Senior Validation Specialist

5 days ago


Alleppey, Kerala, India beBeeValidationEngineer Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Summary:

Our company is seeking a Validation Engineer to join our team. The successful candidate will be responsible for ensuring the validation of computer systems and processes.

  • 5-10 years of experience in computer system validation/quality compliance in a FDA regulated industry (medical device/pharma/life sciences) with a focus on GxP systems.

Mandatory Skills:

  • Strong knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
  • 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.

Requirements:

  • Proven track record of successfully validating computer systems and processes.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a team environment.

We offer:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.


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