IT Compliance Advisor

5 days ago


Thiruvananthapuram, Kerala, India beBeeGxp Full time ₹ 5,00,000 - ₹ 10,00,000

Job Title: GxP Compliance Specialist

We are seeking a skilled GxP Compliance Specialist to join our team.

About the Role:

  • This is a full-time role in an IT compliance environment.

Key Responsibilities:

  • Compliance and Validation:
    • Hands-on experience in compliance and validation roles.
    • Strong knowledge of regulatory standards, including GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.
    • System validation aligned with regulatory standards.
    • Review of validation artifacts and identification of traceability or documentation gaps.
  • System Life Cycle and Methodologies:
    • Well-versed with System Life Cycle.
    • Hands-on experience with Validation approach, Agile methodology, AIML concepts.
  • Testing/Validation Experience:
    • Review and preparation of test plans, validation plans, risk assessments.
    • Requirement Traceability Matrix (RTM), summary reports.
    • Understanding of defect lifecycle and validation deliverables.
  • Tools and Technologies:
    • Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems.
  • Quality & Domain Expertise:
    • Knowledge of Quality Management Systems (QMS).
    • Experience in Healthcare, CRO, or Life Sciences environments.

Requirements:

  • Bachelor's degree in any field.
  • Minimum 4-7 years of experience in IT compliance.

Benefits:

  • A competitive salary package.
  • Ongoing training and professional development opportunities.
  • A collaborative and dynamic work environment.

Educational Qualification: Any Graduate



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