Senior CSV Validation Analyst

Tekskills Inc.; Hyderabad; Presencial; INR 2 500 000 - 4 500 000; Tempo integral

Resumo da oferta

Tekskills Inc. in Noida, Uttar Pradesh, is seeking a Senior CSV Validation Analyst to lead the validation lifecycle for MMIC software systems, ensuring GxP/GAMP5 compliance and robust data integrity.

You will author validation plans, risk assessments, test scripts, and summary reports, coordinate with IT and QA teams, and oversee UAT activities while maintaining cGMP documentation and using Office 365 tools.

Qualificações

• Experience validating and supporting UAT and test scripts.
• Experience authoring CSV lifecycle deliverables (validation plans, risk assessments, testing, reports).
• Experience ensuring SHE, GMP, DI compliance and cGMP validation policies.
• Knowledge of GxP and GAMP5 in GMP environments.
• Ability to lead validation documentation and oversee processes.

Responsabilidades

• Manage the full validation lifecycle of MMIC software systems to ensure GxP/GAMP5 compliance.
• Maintain validation documentation per cGMP and CPI policies.
• Identify computer systems impacting GxP and support validation activities.
• Understand CPI and vendor validation strategies for ongoing projects.
• Lead validation documentation, execution, and oversight.
• Collaborate using Office 365, SharePoint, Teams, SQL, and ALM tools.

Conhecimentos

CSV validation

UAT

Software testing

Documentation

GxP compliance

GAMP5

Leadership in validation

Communication

Ferramentas

ForgeRock Identity Management

Descrição da oferta de emprego

Job Title: Senior CSV Validation Analyst

Location: NOIDA, UP

Skills Required: ForgeRock Identity Management

Exp range:10 & Above

Job Description:

• 1-3 years demonstrated experience with supporting application validation and #UAT.
• Must also demonstrate understanding of how to execute validation related documents such as test scripts.
• Author and support others in the generation of the lifecycle CSV deliverables for each computer system including validation plans, risk assessments, software testing, summary reports, configuration testing and change control.
• To maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
• Manage the validation full lifecycle of the MMIC software systems ensuring that they operate in compliance with GxP GAMP5 requirements.
• Maintain appropriate validation documentation and files according to cGMP and CPI validation policies and procedures.
• To identify and document computer systems which impact upon GxP and aid in the performance of the validation of identified systems.
• To quickly gain a detailed understanding of current CPI and vendor validation strategies and documentation packages for the validation and UAT of ongoing projects.
• Hold expertise in validation procedures and performance in line with GAMP5 guidance and how this is applied to highly complex automated systems.
• Specific understanding of software testing requirements for SCADA, MES, interfaces between IT systems.
• In-depth experience of operating at an expert level in CSV.
• Will possess significant CSV expertise and experience of operating in a GMP environment, developing and implementing validation programs.
• Adherence to Validation and UAT principles.
• Ability to lead by example when it comes to validation documents as well as validation proficiency, execution and oversight.
• Must be able to not only create documents but also oversee the process per established process.
• Office 365, SharePoint, Teams, SQL, ALM validation software or equivalent
• Excellent communication skills both written and verbal.