CSV Expert: Risk-Based Validation & Data Integrity

ICCON Global Consultancy Ltd; Turkey; On-site; TRY 350,000 - 550,000; Full time

Job summary

ICCON Global Consultancy Ltd. seeks an experienced Computerised System Validation (CSV) Expert to support risk-based validation and data integrity activities across GxP environments.

The role leads validation of laboratory, manufacturing, and quality systems in line with 21 CFR Part 11, EU GMP Annex 11, and ISPE GAMP 5, ensuring ongoing lifecycle compliance. The ideal candidate will perform risk-based CSV tasks, document validation activities, and collaborate with QA, IT, and system owners in a

Qualifications

• Hands-on experience performing risk-based CSV for laboratory, manufacturing, and quality systems.
• Strong knowledge of 21 CFR Part 11, EU GMP Annex 11, and ISPE GAMP 5 (2nd Edition).
• Ability to prepare and execute validation documentation (URS, FS/DS, IQ/OQ/PQ, RTM, Validation Summary Reports).
• Excellent written and verbal English; additional languages a plus.

Responsibilities

• Lead risk-based validation of lab, manufacturing, and quality systems.
• Prepare validation documentation (URS, FS/DS, IQ/OQ/PQ, RTM, Validation Summary Reports).
• Apply Data Integrity (ALCOA+) concepts and perform DI risk assessments.
• Collaborate with QA, IT, Engineering, and system owners to maintain lifecycle compliance.
• Ensure systems stay in a continuous state of compliance.

Skills

CSV validation

Data Integrity

Regulatory Compliance

GxP Knowledge

Job description

ICCON Global Consultancy Ltd. seeks an experienced Computerised System Validation (CSV) Expert to support risk-based validation and data integrity activities across GxP environments.

The role leads validation of laboratory, manufacturing, and quality systems in line with 21 CFR Part 11, EU GMP Annex 11, and ISPE GAMP 5, ensuring ongoing lifecycle compliance. The ideal candidate will perform risk-based CSV tasks, document validation activities, and collaborate with QA, IT, and system owners in a