Quality Assurance Validation Lead

JOB DESCRIPTION:

Greetings from TCS!

TCS presents excellent opportunity for QA Validation Lead - Computer System validation for GxP system

JOB DESCRIPTION:

Experience: Experience in Computer System validation for GxP system

Required Skills:

Experience in providing Regulatory Compliance Governance and Strategy consulting

Experience in CSV within R&D, clinical data systems, GxP modules for SAP, Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, manufacturing applications etc.

In-depth knowledge of FDA regulations 21 CFR Part 11 (Electronic Records and Electronic Signatures, Audit Trails and Security events), 21 CFR Part 820, GxP Regulations, GAMP 5, SOX Regulations, EU Annex 11, EU Anness 22, ISO 9001, ITIL processes

Collaborating with IT stakeholders for conducting Regulatory Risk Assessment of quality systems, solutions and services Experience of implementation Risk based approaches for Testing based on CSA fundamentals

Experience of authoring Validation Plan, Validation report based on outcome of GxP, ER,ES Risk Assessment

Review of validation deliverables, including Requirements Specifications (URS/FS), Test Protocols, and Final Reports.

Experience of providing consultation and quality oversight to the IT and Business Stakeholders

Provide Quality support for the Projects and Application and Infrastructure changes

Support of Audit and Inspection Readiness of regulated solutions

Guiding IT stakeholder on Documents and Records Management

Providing recommendations to close the existing compliance gaps and improve the processes

Ensuring compliance to SOPs, policies and procedures

Conducting and coordinating periodic review of GxP applications

Conducting Access Roster review, Audit Trial review processes and finalizing review reports

Experience of using Document management tools such as Valgenesis, Veeva Vault etc

Experience of handling Deviation management, CAPA management