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 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 quick-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 QAIT-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

📌 It - Computer System Validation (csv) Specialist (India)
🏢 Azurity Pharmaceuticals
📍 India