You will be part of a highly engaged team (US-based) managing the operation, maintenance, and development of the 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 projects.
• Provide support for Internal audit / Inspection and facilitate the closure of the identified Audit/Inspection findings.
• Experience to Lead and executing Computer System Validation activities.
• Deep knowledge of 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 the validation life cycle and V-Model.
• Good communication skills and being a quick learner.
• Ability to work as an individual contributor