INNOVATION. PRODUCTIVITY.

VALUE

CSV Lead

Job Description:

You will be part of highly engaged team (US based) managing operation, maintenance and
development of GxP critical IT system, including system corrections and releases as well as the
support process in Agile methodology.

• Responsible for ensuring that GxP/business critical IT systems follow compliance with
internal and external requirements to ensure the validated state.
• Performing review of validation plan/report, URS, FS, TDS, Test plan/report, Qualification
Protocol (IQ, OQ, PQ), test cases and TRM.
• Support release management cycle of the IT System.
• IT Quality coordinator roles at various stages of IT project.
• Provide compliance consulting for the system and contribute towards achievement of
project goals which adherence to Novo Nordisk QMS.
• Provide support for Internal audit / Inspection and facilitating the closure of the identified
Audit/Inspection findings.

Required Skills:

• Experience to Lead and execute Computer System Validation activities.

• Deep knowledge on US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.

• Good validation experience in Veeva Vault /Sparta/Medi Data/Compliance Wire

Implementations.
• Experience in validation of Cloud based platforms (Salesforce, SharePoint etc.)
• Candidate should have experience in performing IQ, OQ and PQ.
• Experience in developing validation deliverables such as URS,Test Plan, Validation Plan,
Test Scripts, VSR, RTM.
• Knowledge of Pharma Regulatory Compliance in CSV.
• Knowledge of End-to-End CSV in GxP environment with experience in validation life cycle
and V-Model.
• Good communication skills and be a quick learner.
• Ability to work as an individual contributor