IN_Associate_CSV_ITRA_Advisory_Hyderabad

Own and execute Computer System Validation (CSV) activities including authoring validation deliverables such as Validation Plan, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Report.

Conduct manual testing (positive, negative, regression, smoke, sanity) with defect tracking and reporting to ensure software compliance and quality.

Apply knowledge of regulatory standards (GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+) and change control processes (Deviation Management, CAPA, Periodic Review) in validation efforts.

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

Bachelor's degree in Pharmacy (B.Pharm) required; Bachelor of Engineering preferred but not mandatory.

Mandatory skills include Computer System Validation (CSV); knowledge of LIMS/QMS is preferred.

Experience with SDLC methodologies (Waterfall, Agile, V model) and manual testing techniques required.

Experienced in regulated industries requiring adherence to GxP and FDA regulations with hands-on CSV and testing expertise.

Capable of working with various validation documentation and processes including risk assessments (FMEA) and compliance auditing.

Familiarity with CSV tools such as Valgenesis and knowledge of laboratory/instrument management systems (LIMS) or quality management systems (QMS) is advantageous.