IN_Senior Associate_CSV_Advisory_Bangalore

Seeking a Computer System Validation (CSV), Software Testing and IT Compliance.
Requires experience in validation deliverables, manual testing, SDLC/STLC, GxP regulations and compliance processes, with LIMS/QMS as preferred skills.

Responsibilities

Having 4-8 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance.
Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles.
Knowledge of Change Control, Deviation Management, CAPA and Periodic Review.
Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications(URS), Functional Requirement Specifications(FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR)

Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC).
Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV.
Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting. (Preferred exposure to CSV tools such as Valgenesis)
4-8 years

B.Pharm/ M.Pharm/ Other Post graduation