Validation Specialist

5 days ago


Bayan Lepas, Penang, Malaysia Greatech Technology Full time
Job Summary

We are seeking an experienced Validation Specialist to join our team at Greatech Technology. The successful candidate will be responsible for developing and implementing validation protocols and procedures to ensure compliance with regulatory requirements.

Key Responsibilities:
  • Design and develop validation protocols and procedures to ensure compliance with regulatory requirements.
  • Conduct validation activities, including installation qualification, operational qualification, and performance qualification.
  • Collaborate with cross-functional teams to identify and mitigate validation risks.
  • Analyze data to identify trends and areas for improvement in validation performance.
  • Develop and maintain procedures and work instructions to ensure consistent application of validation principles.
Required Skills and Qualifications:
  • Bachelor's degree in Engineering, Science, or a related field.
  • Minimum 2-5 years of experience in validation or a related field.
  • Strong knowledge of FDA 21 CFR Part 11 and other relevant industry standards.
  • Excellent communication and interpersonal skills.
  • Ability to analyze complex data and develop recommendations for improvement.

Benefits: Competitive salary, comprehensive benefits package, and opportunities for career growth and development.



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