IT - Computer System Validation (CSV) Specialist

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Brief team/department description:

At Azurity, our Digital team is at the forefront of building transformative capabilities through next-generation Digital Enterprise Applications. We're on the lookout for a bold, growth-oriented IT – Computer System Validation (CSV) Specialist who thrives in fast-paced environments, embraces change, and isn’t afraid to take smart risks. If you're passionate about compliance, innovation, and continuous learning, we want to hear from you.

We are seeking a IT – Computer System Validation (CSV) Specialist with deep expertise in the pharmaceutical domain. This role plays a pivotal part in ensuring that IT systems and regulated environments adhere to stringent industry standards, including 21 CFR Part 11, Annex 11, GxP, and other relevant regulatory frameworks.

The ideal candidate will have hands-on experience in authoring, reviewing, and managing CSV documentation, ensuring that systems are not only compliant but also aligned with business objectives. You’ll collaborate across teams to validate enterprise applications and support digital transformation initiatives with a strong compliance backbone.

 Principle Responsibilities:

• Develop, review, and execute the IT-CSV deliverables like Validation Plan, Validation Summary Report, Trace Matrix, IQ/OQ/PQ protocols (Installation Qualification, Operational Qualification, Performance Qualification) for computer systems, applications, and IT infrastructure.
• Conduct risk assessments for validation projects and identify mitigation strategies.
• Perform risk-based validation to prioritize testing efforts based on system impact.
• Ensure that all validation documentation (URS, traceability matrices, validation reports, etc.) is complete, accurate, and in compliance with applicable regulations and internal SOPS.
• Interface with key IT and business stakeholders to understand requirements.
• Provide subject matter expertise for IT impacts requiring CSV verification and validation, including to GxP and other validation requirement as applicable.
• Create and ensure proper documentation is created for testing of validated systems.
• Interface with the Enterprise Program Management Office to incorporating IT QA activities into broader project plans and timelines.

Qualifications and Education Requirements

• Bachelor’s degree in Computer Science, Information Management, or related field.
• 5+ years in an IT QA\IT-Computer System Validation(CSV) position, preferably in life sciences/pharma.
• In-depth understanding of regulatory standards such as 21 CFR Part 11, GxP, FDA, and EU GMP Annex 11.
• Relevant knowledge on Information Technology, Pharmaceutical or Medical Device experience.
• Knowledge of GxP and other validation requirements in the pharmaceutical industry.
• Self-starter who is well organized and is an effective communicator who takes the initiative in meeting personal, departmental, and corporate goals.
• Capable of working both independently and within a team.
• Ability to work on-site in Hyderabad in a modified shift with partial US overlap.
• Excellent verbal and written English skills.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.