Senior CSV Validation Analyst

Tekskills Inc.; Mumbai; Vor Ort; INR 1.800.000 - 2.400.000; Vollzeit

Zusammenfassung

Tekskills Inc. in Noida is seeking a Senior CSV Validation Analyst to lead CSV lifecycle activities within GMP/GxP contexts and ensure compliance across MMIC software systems. You will develop validation plans, create and execute test scripts, and oversee UAT while maintaining thorough documentation.

Experience with GAMP5, cGMP policies, and data integrity is essential, along with strong communication skills and collaboration across cross-functional teams for successful project delivery.

Qualifikationen

• 1-3 years demonstrated experience with supporting application validation and UAT.
• Understanding of how to execute validation related documents such as test scripts.
• Ability to author and support others in generating the lifecycle CSV deliverables for each computer system including validation plans, risk assessments, software testing, summary reports, configuration testing and change control.

Aufgaben

• Maintain consistent and documented compliance with Safety, Health and Environmental (SHE), GMP, Data Integrity (DI) and best practice requirements.
• Manage the validation full lifecycle of MMIC software systems ensuring alignment with GxP GAMP5 requirements.
• Maintain appropriate validation documentation and files according to cGMP and CPI validation policies and procedures.
• Identify and document computer systems which impact upon GxP and support validation of identified systems.
• Gain a detailed understanding of current CPI and vendor validation strategies and documentation for ongoing projects.
• Adhere to validation and UAT principles and lead by example in documentation quality and validation proficiency.

Kenntnisse

ForgeRock Identity Management

Tools

Office 365

SharePoint

Teams

SQL

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.