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.

Overview:

We are seeking an experienced IT - Computer System Validation (CSV) Specialist with a strong background in the pharmaceutical industry. This role is responsible for ensuring that IT systems and software applications used in manufacturing, laboratory, and other regulated environments are compliant with industry regulations such as 21 CFR Part 11, GxP, and other regulatory requirements. The ideal candidate will have experience in leading and executing validation activities, performing risk assessments, developing and executing validation protocols, and ensuring the integrity and security of data within a highly regulated environment.

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 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\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 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.

Physical & Mental Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to sit for long periods of time
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
• May occasionally climb stairs and/or ride elevators
• The employee must occasionally lift and/or move up to 25 pounds
• Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
• Other miscellaneous job duties as required