Seeking an experienced Senior Consultant with a strong background in SAP, CSV, and DSA, specifically within the Life Sciences and Healthcare (LSHC) industry. This role is based in Hyderabad, India, and requires a deep understanding of computerized system validation processes in regulated environments.

Ideal candidates will possess a minimum of 5 years of hands-on experience as a Computer System Validation Professional. This includes extensive work with enterprise-level applications such as ERP, MRP, QMS, and LIMS, supporting global business operations. The position emphasizes building robust validation strategies for agile and rapid delivery.

The role involves defining and executing end-to-end validation activities for IT projects and system upgrades, alongside collaborating with cross-functional teams to ensure validation needs are met. A key aspect is the creation and review of critical validation deliverables, ensuring compliance with all relevant standards.

Drive Computerized System Validation (CSV) efforts, acting as a Validation Subject Matter Expert to support business requirements, technical designs, and test strategies. Develop and implement agile validation strategies to accelerate delivery. Lead end-to-end validation activities for IT projects, system releases, and upgrades.

Collaborate effectively with domain and enterprise resources to meet system validation requirements. Create and review essential validation documentation, including GxP Assessments, Validation Plans, URS, FRS, DS, Configuration Specifications, IQ, OQ, PQ, test reports, and Validation Summary Reports. Manage data migration for validated systems and provide support for cloud validation, supplier assessments, AI/ML validation, and infrastructure qualification.

Perform periodic reviews of IT systems, including user reviews, to maintain validated states. Handle deviations, conducting Root Cause Analysis (RCA) using methods like the 5x Why approach and implementing CAPA. Manage change requests during the operational phase and conduct requirement and IT risk assessments, including data privacy tasks. Support supplier assessments and provide guidance. Define and review test strategies and cases, assist with internal audits and inspections, and participate in project teams to define schedules and validation levels.

Requires a minimum of 8 years of experience in quality assurance and/or computerized system validation within the life sciences and healthcare (LSHC) industry. Must demonstrate knowledge of and experience with regulatory requirements such as GMP, 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11.

Possess at least 5 years of relevant work experience as a Computer System Validation Professional, with hands-on experience in domain systems like ERP, MRP, QMS, and LIMS. Should be adept at defining and executing end-to-end validation for IT projects and system upgrades, fostering strong working relationships and collaboration.

Proficiency in creating and reviewing validation deliverables including IQ, OQ, PQ test plans and reports, GxP Assessments, and Validation Summary Reports. Experience with data migration for validated systems is essential. Exposure to cloud validation, supplier assessment, AI/ML validation, and infrastructure qualification is highly desirable.

Skilled in deviation handling, RCA (e.g., 5x Why), and CAPA, as well as managing change requests and conducting risk assessments (requirement, IT, and data privacy). Must have excellent written and oral communication skills, the ability to deal with ambiguity, self-confidence, good interpersonal skills, and the capacity to collaborate effectively with stakeholders. Flexibility and the ability to work under strong time pressure are crucial.