DEMO S.A. Pharmaceutical one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a high caliber Head of Computerized Systems Quality Management activities in Kryoneri.

Responsibilities

• Ensure that SOPs are in place and followed for validation, maintenance and data integrity of GxP critical systems.
• Train CSQM analysts
• Create and manage CSQM team schedules
• Coordinate with CSQM Analysts to prioritize and support validation activities
• Evaluate team performance and provide feedback
• Lead or support day-to-day validation activities in accordance with approved CSV SOPs/plans/policies.
• Coordinate with IT regarding implementation/installation of GxP critical sys-tems, preparation of SOPs related to GxP data backup and GxP CS mainte-nance.
• Identify key roles and responsibilities for GxP critical systems in collaboration with stakeholders (e.g. process owners, system owners, administrators, end users).
• Participate in system design reviews to ensure compliance with user require-ments, good engineering practices, validation requirements, and regulatory standards.
• Perform risk and gap assessments against current policies for GxP critical sys-tems.
• Support, review and ensure execution of technical and GxP related documen-tation (e.g. Validation Plan/Report, URS, FS, Test Protocols/Reports).
• Liaise with end users or external contractors to ensure validation activities are completed as planned and in accordance with user requirements.
• Oversee and support the lifecycle management of validated software systems (e.g. change management, configuration management, periodic review, sys-tem retirement).
• Establish and maintain computer system validation master plan.

• BSc Degree in Informatics, Computer Engineering, Chemistry, Biology or Pharmacy.
• Minimum 2 years of experience in similar Quality Assurance CSV role in Pharmaceutical Industry.
• Fluent oral and written skills in Greek & in English
• Computer literacy
• Self-motivated & results oriented with ability to cope with strict timelines
• Ability to deliver on complex project requirements and tasks
• Ability to work creatively, analytically with attention to detail

The company offers competitive compensation, continuous training & career development opportunities and a friendly working environment.