PharmaPath, a Greek pharmaceutical company with a rich history and significant legacy in the pharmaceutical field of generic medicines, is seeking a dedicated and skilled Computerized Systems Quality Engineer to join our dynamic team. 

Main duties and responsibilities:

The engineer will provide quality oversight for GxP computerized systems in a regulated pharmaceutical environment. The role will be responsible for ensuring that computerized systems meet quality, compliance, validation, and data integrity requirements throughout their lifecycle.

The engineer will work closely with Quality Assurance, IT, Engineering, Manufacturing, Validation, and external vendors to ensure systems operate in compliance with EMA, GAMP 5, Annex 11, and 21 CFR Part 11 requirements.

• Ensure computerized systems comply with internal SOPs and regulatory expectations.
• Support development and review of SOPs and work instructions.
• Train users on quality and compliance expectations for computerized systems.
• Co-ordinate preparation of User Requirements / Functional / Design Specifications for computerized systems that support GMP-critical processes as well as of Testing & Validation Scenarios (Unit tests, Validation plans & reports, Traceability matrices) to ensure Installation, Operational & Performance Qualification (IQ/OQ/PQ), in co-operation with relevant Business Units.
• Review IT systems specifications & configuration for GMP-readiness to ensure they meet guidelines for Traceability, Accountability and Data Integrity.
• Co-ordinate projects for delivery of GMP-critical Computerized Systems.
• Specify & ensure execution of processes for IT systems Configuration Management, Error handling, Backup & Recovery, Contingency Planning, etc.
• Support Infrastructure qualification requirements.
• Contribute to handling of deviations, CAPAs, and change controls related to computerized systems.
• Participate in regulatory inspections and customer audits.
• Support responses to related audit observations and regulatory findings.
• Assess data integrity risks associated with computerized systems.
• Ensure appropriate audit trail functionality, electronic signatures, and access controls are implemented.
• Perform risk assessments using quality risk management principles.
• Support periodic system reviews and continuous compliance monitoring.
• Co-ordinate qualification of third-party software providers.

Requirements:

• University degree preferably in Electrical/Electronic/Computer Engineering, Information Technology, Computer Science or related discipline.
• Knowledge of GMP standards & regulations and/or pharmaceutical Computerized System Validation (CSV) procedures.
• 2 years of experience in pharmaceutical Quality Assurance, CSV, or computerized systems compliance.

Benefits:

• Competitive remuneration package, including benefits
• Ability to become part of one of the most dynamic and prospective teams in the Pharmaceutical industry in Greece
• Continuous opportunities in advancing personal and career goals