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Software Quality & Validation Lead
ConfidentialHyderabad / Secunderabad, Telangana30+ days ago
Job descriptionRoles & Responsibilities : Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications. Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ / OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Contribute to test automation scripting, framework maintenance, and CI / CD integration. Implement automated test suites across various layers including data pipelines, APIs, and semantic layers. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with multi-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Supervise the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Find opportunities for process improvements in validation activities. Stay ahead of on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications :
- Master s degree with 4-6 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR
- Bachelor s degree with 6 - 8 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience OR
- Diploma with 10 - 12 years of experience in Life Science / Biotechnology / Pharmacology / Information Systems experience
- Must-Have Skills : 5+ years of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc).
- 8-10 Years overall experience in Testing & Validation Projects
- 3 to 5 years overall experience in QA & Test Automation is expected.
- Experience leading software validation projects.
- Proficiency in developing and implementing validation protocols (IQ, OQ, PQ), reports, and related documentation.
- Hands-on experience implementing and analyzing automated test suites
- Familiarity with computer system validation and software validation is a plus.
- Strong problem-solving and analytical skills.
- Excellent communication and teamwork skills.
- Experience with automated and computer-controlled systems validation (21 CFR Part 11)
- Soft Skills :
- Excellent analytical and troubleshooting skills.
- Strong verbal and written communication skills
- Ability to work effectively with global, virtual teams
- High degree of initiative and self-motivation.
- Ability to handle multiple priorities successfully.
- Team-oriented, with a focus on achieving team goals.
- Ability to learn quickly, be organized and detail oriented.
- Strong presentation and public speaking skills.
Preferred Qualifications :
Good-to-Have Skills :
Skills Required
Test Automation
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Quality Lead • Hyderabad / Secunderabad, Telangana