Senior CSV Validation Analyst

Tekskills Inc.; Chennai; On-site; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Health benefits

Job summary

Tekskills Inc. is seeking a Senior CSV Validation Analyst to support validation and UAT activities for MMIC software systems in a GMP environment. The role requires deep CSV expertise, familiarity with GxP concepts, and ability to generate and oversee validation documentation across the full lifecycle.

Strong communication and documentation skills are essential. The ideal candidate will work on validation plans, risk assessments, software testing, and change control, ensuring adherence to GAMP5

Qualifications

• 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.
• Maintain consistent and documented compliance with all relevant SHE, GMP, DI, quality and best practice requirements.
• Manage the validation full lifecycle of MMIC software systems ensuring compliance with GxP GAMP5 requirements.

Responsibilities

• Lead by example in validation document creation, execution, and oversight.
• Maintain appropriate validation documentation according to cGMP and CPI validation policies.
• Identify and document computer systems impacting GxP and aid in validation of identified systems.
• Gain understanding of CPI and vendor validation strategies for ongoing projects.

Skills

CSV validation

UAT

Software testing

GxP compliance

GAMP5 guidance

Communication

Tools

Office 365

SharePoint

SQL

ALM validation software

Teams

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.