Our Client, a well known Pharmaceutical company is looking for an experienced Computer System Validation Senior Specialist to lead computer system validation across manufacturing, QC, and warehouse operations, ensuring regulatory compliance and data integrity within the QA Validation team.
- Lead CSV projects, ensuring systems comply with regulatory and data integrity requirements from validation through operational use.
- Assess and manage software and hardware changes, performing risk assessments and ensuring compliance throughout the validation lifecycle.
- Prepare, execute, and maintain CSV protocols and documentation according to FDA, EU GMP, and company standards.
- Serve as the CSV Subject Matter Expert during internal and external audits.
- Support equipment qualification and coordinate vendor-led periodic qualifications.
- Assist with quality investigations, including deviations, CAPAs, and complaints, in collaboration with the Quality Unit.
Working Hours: Monday - Friday
Requirements
- Hands-on CSV experience in regulated pharma or life sciences.
- Candidates must already be based in Malta, with the legal right to work in Malta.
- Hold an excellent level of written and verbal English.
- Solid knowledge of GAMP 5 and risk-based validation and data integrity.
- Detail-oriented with the ability to produce clear, compliant validation documents.
- Able to prioritise and lead tasks in a compliance-driven environment.
Education and Experience
- Graduate in a relevant field, ideally life sciences, with a strong IT background.
Benefits
- Health Insurance
- Annual Performance Bonus
Job Reference: QC391
