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Validation Engineer

2 months ago

Ahmedabad, India TIGI HR ® Full time

Job Description:


We are seeking a Validation Engineer with 2-4 years of experience to ensure the quality and compliance of our systems and processes. The ideal candidate will have a background in IT/Computer Science and possess some validation experience. Knowledge of Gxp, 21CFR Part 11, and GAMP 5 is essential for success in this role.


Key Responsibilities:

  • Develop and execute validation documents, including the Validation Master Plan, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification.
  • Ensure that all validation activities adhere to relevant global regulations such as GAMP 5, Title 21 CFR Part 11, EU Annexures 11, and PIC.
  • Collaborate with cross-functional teams to ensure the validation of IT systems and equipment.
  • Provide support and guidance to maintain compliance in a pharmaceutical environment, if previously experienced.
  • Continuously stay updated with industry best practices and standards to enhance the validation process.


Qualifications:

  • Bachelor's degree in IT, Computer Science, or related field.
  • 2-4 years of validation experience.
  • Familiarity with Gxp, 21CFR Part 11, and GAMP 5.
  • Strong attention to detail and analytical skills.
  • Excellent communication and teamwork abilities

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