Senior CSV Validation Analyst

Tekskills Inc.; Delhi; Vor Ort; INR 1.800.000 - 3.200.000; Vollzeit

Zusammenfassung

Tekskills Inc. in Noida, UP seeks a Senior CSV Validation Analyst to lead CSV validation programs for MMIC software systems. You will own validation plans, risk assessments and change control across GMP-compliant environments. Strong expertise in GAMP5 and UAT is required, with hands-on testing and document oversight.

Candidate should demonstrate excellent communication skills and the ability to drive validation deliverables through cross-functional teams in a highly regulated setting.

Qualifikationen

• 10+ years of CSV validation experience.
• Experience supporting validation deliverables and UAT.
• Knowledge of GMP/SHE data integrity practices.
• Familiarity with validation documentation and change control.

Aufgaben

• Author and support others in generation of CSV deliverables including validation plans and risk assessments.
• Conduct software testing, provide summary reports and perform configuration testing.
• Ensure compliance with GMP, GxP, DI and related policies.
• Manage validation lifecycle of MMIC software systems to meet GxP/GAMP5 requirements.
• Maintain validation files per cGMP policies and identify systems impacting GxP.

Kenntnisse

CSV validation

UAT

Test scripts

GxP compliance

GAMP5

Tools

SQL

SharePoint

Office 365

ALM validation software

Jobbeschreibung

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.