Digital Systems Validator

16 hours ago


Hyderabad, Telangana, India beBeeCsv Full time ₹ 20,00,000 - ₹ 25,00,000

Azurity Pharmaceuticals, a specialty pharmaceutical company focusing on innovative products for underserved patients, seeks a motivated IT professional.

The company's patient-centric products span multiple markets and have benefited millions of patients. We are an inclusive workplace and an Equal Opportunity Employer.

We are looking for individuals with dedication, integrity, and creative spirit needed to thrive in our organization.

Digital Team Overview:

Our Digital team builds transformative capabilities through next-generation Digital Enterprise Applications. We're seeking a bold, growth-oriented CSV Specialist who thrives in fast-paced environments, embraces change, and takes smart risks.

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.

Key Responsibilities:

  • Develop, review, and execute CSV deliverables like Validation Plan, Validation Summary Report, Trace Matrix, IQ/OQ/PQ protocols 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 validation documentation 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.

Qualifications and Education Requirements:

  • Bachelor's degree in Computer Science, Information Management, or related field.
  • 5+ years in 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 knowledge on Information Technology, Pharmaceutical or Medical Device experience.
  • Self-starter who is well organized and is an effective communicator.
  • Capable of working both independently and within a team.


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