N · Senior Associate · CSV · Advisory · Bangalore

Job Description & Summary

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.

Job Position Title

IN_Senior Associate_CSV_Advisory_Bangalore

Responsibilities

· Having 4-8 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance.

· 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)

· 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)

Mandatory skill sets

CSV

Preferred skill sets

LIMS/QMS

Years of experience required

4-8 years

Education qualification

B.Pharm/ M.Pharm/ Other Post graduation