QA Specialist - CSV

Computerized System Validation (CSV) Specialist responsible for validating and maintaining the compliant state of GxP computerized systems and software throughout their lifecycle, ensuring alignment with EU-GMP, GAMP 5, data integrity, and applicable ISO requirements.

• Execute and coordinate CSV activities for computerized systems and software in compliance with EU-GMP and GAMP 5.
• Manage the validation lifecycle from URS through Final Qualification/Validation Report, including risk assessments, impact assessments, protocols, testing, and documentation.
• Perform and support revalidation, periodic reviews, and change control activities to maintain the validated state of computerized systems.
• Validate/revalidate SAP and other GxP computerized systems in accordance with EU-GMP Annex 11, GAMP 5, and Data Integrity requirements.
• Prepare and review SOPs, URS, risk assessments, impact assessments, validation protocols, test scripts, and validation reports.
• Review supplier/vendor documentation and assess its suitability for validation activities.
• Support qualification and validation of systems integrated with equipment, utilities, HVAC, water treatment, and other GMP systems, where applicable.
• Ensure CSV activities comply with applicable EU-GMP and ISO standards, including ISO 9001, 14001, 45001, 17025, and 50001 where relevant.
• Train system users on newly implemented or upgraded computerized systems and related procedures.
• Provide CSV input for change controls, deviations, CAPA, and system modifications.
• Ensure computerized systems remain compliant throughout their lifecycle and support inspection/audit readiness.
• Ensure activities comply with MEVAC QHSE and EU-GMP requirements and applicable emergency procedures.

• Bachelor’s degree in Computer Science, Information Technology, Engineering, Science, Veterinary, or a related technical/scientific field.
• Minimum 1 year of relevant experience in Computerized System Validation (CSV) or QA Validation
• Previous experience in a pharmaceutical, biopharmaceutical, vaccine, medical device, or other GMP-regulated environment is preferred.
• Practical knowledge of GAMP 5, EU-GMP Annex 1 & QHSE
• Practical understanding of the CSV lifecycle, including URS, risk assessment, specifications, IQ/OQ/PQ, testing, traceability, validation reporting, periodic review, change control, and system retirement.
• Knowledge of computerized system controls including user access, audit trails, electronic signatures, backup/recovery, data retention, and data integrity.
• Strong technical documentation and report-writing skills.
• Strong analytical and problem-solving skills with attention to detail.
• Good communication and cross-functional collaboration skills.
• Good command of English and Microsoft Office.

• Social, Medical and Life Insurance
• Pension Coverage
• Profit Share
• Quarterly Balanced Scorecard
• Transportation from certain points