Senior Regulatory Compliance Specialist

4 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulator Full time ₹ 9,00,000 - ₹ 12,00,000
Job Description:

As a key member of the regulatory compliance team, you will play a pivotal role in ensuring the quality and integrity of computerized systems within our organization.

Major accountabilities include:

  • Quality oversight of projects and operational activities related to GxP systems, including changes, periodic reviews, deviations, and more. You will provide critical support to meet applicable Novartis and regulatory requirements for GxP regulated computerized systems projects.
  • Act as a primary point of contact for all CSV-related matters within GxP Computerized Systems and serve as an interface between IT and Business for eCompliance topics related to GxP classified Computer Systems, promoting a Quality Culture.
  • Review and approve project-related documents for GxP relevant systems, including determination of GxP applicability for all GxP and non-GxP relevant systems.
  • Establish trusted partnerships with assigned IT functions, demonstrating a deep understanding of business drivers and providing essential day-to-day operational support.
  • Review and approve GxP-impacted deviations, ensuring appropriate CAPAs are implemented.
  • Contribute to the preparation of VMPs and execute plans for associated systems within respective functions.
  • Review and approve Periodic Review Reports for GxP computerized systems and address gaps within the CAPA Management System.
  • Perform supplier qualification assessment activities.
  • Provide audit support as assigned and offer required Quality support in case of CAPAs.
Required Skills and Qualifications:

Work Experience:

  • A minimum of 5-10 years of overall experience, with at least 4 years of relevant experience in the Pharmaceutical Industry, particularly in regulated functions such as IT Quality and Compliance.

Skills:

  • Good understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.).
  • Significant experience in the development, implementation, and lifecycle management of computerized systems in regulated environments.
  • Expertise in operational management of GxP solutions, including related technologies to support operations.
Benefits:

The ideal candidate will have a strong background in regulated industries, excellent communication skills, and the ability to work effectively in a fast-paced environment.

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