Job title: Computer System Validation Consultant

Company: Tata Group

Job description: Must-Have** (Ideally should not be more than 3-5) 1. Knowledge of End-to-End CSV in GxP environment with deep experience in validation life cycle. 2. Good understanding of Pharma Regulatory requirements including CFR Part 11, Annex 11, Good Doc

Must-Have** (Ideally should not be more than 3-5) Knowledge of End-to-End CSV in GxP environment with deep experience in validation life cycle. Good understanding of Pharma Regulatory requirements including CFR Part 11, Annex 11, Good Documentation Practices , GAMP5 guidelines and various other regulations. Experience in V-Model, Agile and Validation life cycle of regulated projects Experience in supporting external audits. Candidates should be good in reviewing the Requirements, Test Cases and other SDLC related documentation. Good-to-Have A combination of work experience in Quality and Testing is a plus. Knowledge of HP ALM, JIRA, Documentum, PDOC’s, Confluence Periodic Review experience. Knowledge on Pharmacovigilance, GLP system. Expsoure on Lab valiation, instrument valiation. SN Responsibility of / Expectations from the Role 1 Leads validation projects as assigned and serve as a validation team member on multiple assignments as designated by the manager with support from other team members as needed. 2 Writes and assembles critical validation documentation packages including the Validation Plan, Testing Results, Traceability Matrix, IQ, OQ (RSV), PQ and Validation Report. 3 Test execution and defect management 4 Maintains and utilizes a strong knowledge of SOP’s and validation work procedures/standards in relation to the System Development Life Cycle. 5 Review and approvals of SDLC/GRC deliverable

Expected salary:

Location: Bangalore, Karnataka

Job date: Wed, 27 Apr 2022 22:32:54 GMT

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