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Azurity Pharmaceuticals
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IT - Computer System Validation (CSV) Specialist

IT - Computer System Validation (CSV) Specialist

Azurity Pharmaceuticals

5 - 10 years

7 - 12 Lacs

hyderabad

Posted:None| Platform:

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Skills Required

computer science computer system validation neurology cardiovascular pharma life sciences gmp information management operations endocrinology

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

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IT - Computer System Validation (CSV) Specialist