Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

10 years minimum

Working hours

Regular working hours

Job source

www.dice.com

Tech stack

Data Integrity System Testing Iq/oq/pq GXP

Requirements

• Experience in Computer System Validation (CSV) within the Pharmaceutical/Life Sciences industry.
• Strong knowledge of GxP, FDA 21 CFR Part 11, GAMP 5, and data integrity requirements.
• Experience preparing/reviewing URS, FRS, Risk Assessments, IQ/OQ/PQ, Validation Plans and Reports.
• Hands-on experience with validation of GxP computerized systems and related documentation.
• Knowledge of change control, deviation, CAPA, and SOPs.
• Experience working with QA/Validation teams and supporting audits/inspection readiness.
• Strong documentation and communication skills.

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