20 Aug
|
Tekskills
|
Noida
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 workplace, 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 docume
📌 Senior CSV Validation Analyst (Noida)
🏢 Tekskills
📍 Noida