Information Security GxP Specialist

2 days ago


Hyderabad, Telangana, India Amgen Inc Full time
Job Description

Basic Qualifications:

- 5+ years of experience in IT GxP deviation management, IT quality management, IT auditing, or information security.
- Hands-on experience with deviation management tools and associated frameworks (e.g., ISO 27001, NIST, COBIT).
- Master's degree and 4 to 6 years of information technology, Cybersecurity, Risk Management, or a related field experience OR
- Bachelor's degree and 6 to 8 years of information technology, Cybersecurity, Risk Management, or a related field experience OR
- Diploma and 10 to 12 years of information technology, Cybersecurity, Risk Management, or a related field experience

Preferred Qualifications:

- Good understanding of GxP deviation management, controlled document management, IT infrastructure & systems, and security standard methodologies.
- Ability to assess technical and business risk related to information systems.
- Excellent problem-solving, analytical, and communication skills.
- Ability to communicate complex GxP and risk concepts to non-technical collaborators.
- Familiarity with regulatory frameworks and compliance standards (e.g., GxP, GDPR, HIPAA, SOX).

Technical Knowledge:

- Proficiency with GxP deviation management tools, GRC (Governance, Risk, and Compliance) software, controlled document management tools, enterprise change management tools, and security incident management tools.
- Experience with security controls related to networks, databases, and cloud environments.

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