Senior CSV Validation Analyst

Tekskills; Dadri; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Tekskills is seeking a Senior CSV Validation Analyst in Noida to lead the full lifecycle validation of MMIC software systems in a GMP environment. You will craft validation plans, risk assessments, and test scripts while ensuring data integrity and compliance with GxP and GAMP5 standards.

You will author and oversee validation documentation, including IQ/OQ/PQ and change control, and manage UAT activities. Strong communication and Office 365/ALM tool proficiency are required.

Qualifications

• Experience with validation and UAT processes in a GMP environment.
• Ability to author and support validation documents including validation plans and risk assessments.
• Strong understanding of CSV deliverables and software testing within GxP contexts.
• Familiarity with GAMP5 guidance and related compliance requirements.
• Proficiency with Office 365 tools and ALM validation software for documentation.

Responsibilities

• Lead full lifecycle CSV validation for MMIC software systems.
• Develop and maintain validation plans, risk assessments, and test scripts.
• Produce and review CSV deliverables including IQ/OQ/PQ and change control.
• Ensure compliance with GMP, cGMP, DI, SHE standards across projects.
• Coordinate validation activities and oversee execution and documentation.

Skills

ForgeRock Identity Management

Tools

Office 365

SharePoint

Teams

SQL

ALM validation software

Job description

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.