Validation Lead

2 days ago

Hyderabad, Telangana, India Amgen Inc Full time
Job Description

Must-Have Skills:

- 2+ year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.).
- 5+ to 9Years overall experience in Testing with 2+ years of experience in validation experience is mandatory.
- Experience leading software validation projects.
- Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation.
- Familiarity with computer system validation and software validation is a plus
- Strong problem-solving and analytical skills
- Excellent communication and teamwork skills.

Good-to-Have Skills:

- Experience with automated and computer-controlled systems validation (21 CFR Part 11)
- Education and Professional Certifications
- Bachelor's /Masters degree in computer science and engineering preferred, other Engineering field is considered

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