Senior Validation officer

Tabuk Pharmaceuticals; Tabuk; On-site; SAR 200,000 - 300,000; Full time

Job summary

A leading pharmaceutical company in Saudi Arabia seeks a CSV Engineer to plan and execute Computer System Validation activities, ensure compliance, and support Data Integrity assessments. The role includes preparing documentation, collaborating with various departments, and mentoring junior engineers. Candidates should have experience with GMP standards and knowledge of systems like LIMS and SAP. This position offers a pivotal role in ensuring data compliance and system integrity.

Qualifications

• Experience with GMP and GAMP 5 standards.
• Knowledge of IQ and OQ for equipment qualification.
• Experience in regulatory inspections and audits.

Responsibilities

• Plan and execute CSV activities.
• Perform DI assessments in QC labs.
• Prepare and review CSV documentation.
• Support regulatory inspections and audits.

Skills

Computer System Validation (CSV)

Data Integrity (DI)

Risk assessments

Change management

LIMS

eQMS

SAP

Job description

Key Responsibilities

• Plan & execute Computer System Validation (CSV) activities in compliance with GMP, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
• Perform and support Data Integrity (DI) assessments and remediation activities in QC laboratories and manufacturing environments.
• Participate in and lead data analysis, gap assessments, and risk assessments related to CSV and DI.
• Support qualification activities including IQ and OQ (Equipment , system and utilities qualification knowledge for sterile and non-sterile manufacturing is advantage)
• Prepare, review, and approve CSV documentation such as URS, FS/DS, Risk Assessments, Validation Plans, Protocols, Reports, and Traceability Matrices.
• Support validation and ongoing compliance of computerized systems including:
  • LIMS
  • eQMS
  • SAP and related modules
• Ensure validated systems remain in a state of control through change management, periodic reviews, and incident management.
• Collaborate with QC, Manufacturing, IT, Engineering, and external vendors during system implementation and upgrades.
• Support regulatory inspections and audits (EU, FDA, and other health authorities).
• Mentor junior CSV engineers and contribute to continuous improvement initiatives.
• Plan and perform data flow map in different system specially in library environments