IN_Senior Associate_CSV_Advisory_Bangalore

PwC India; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Price Waterhouse Cooper LLP in Bengaluru seeks a Senior Associate CSV Advisory to contribute to validation deliverables and IT compliance engagements across GxP environments.

You will apply knowledge of CSV/validation activities, participate in SDLC/STLC processes, and author validation documents such as VP, URS, FRS, IQ/OQ/PQ, and VSR under guidance.

4–8 years of relevant experience is required, with preferred exposure to LIMS/QMS systems and regulatory standards such as FDA/Annex 11.

Qualifications

• 4-8 years of experience in CSV, software testing and IT compliance.
• Exposure to SDLC and STLC, with Waterfall/Agile and V-model.
• Knowledge of GAMP5, GxP, FDA 21 CFR Part 11, EU Annex 11 and ALCOA+.

Responsibilities

• 4–8 years in CSV, software testing and IT compliance.
• Exposure to SDLC and STLC, with Waterfall/Agile and V-model.
• Experience in manual testing and defect tracking; Valgenesis exposure preferred.
• Knowledge of GAMP5, GxP, FDA 21 CFR Part 11, EU Annex 11 and ALCOA+.
• Authoring deliverables: VP, URS, FRS, FRA/FMEA, DS, IQ/OQ/PQ, VSR.
• Change Control, Deviation, CAPA, Periodic Review experience.

Skills

CSV

Manual testing

GxP compliance

Defect tracking

Education

B.Pharm / M.Pharm / Other Post graduation

Tools

Valgenesis

Job description

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