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.
Top Skills
What We Do
DEMO is a dynamic Greek industrial and commercial organization, specializing in the development, production and supply of pharmaceutical products.
The company is the largest supplier of injectables for public hospitals in Greece, exports 80% of its annual production and is recognized as one of the official suppliers of the United Nations, UNICEF, the World Health Organization (WHO), Doctors Without Borders and the International Committee of the Red Cross. With over 3,300 circulation licenses in 86 countries worldwide, the largest factory in SE Europe and over 1,400 employees, DEMO paves the way for pharmaceutical self-sufficiency for Greece and Europe.
Today, DEMO implements investments of €356 million, strengthening production and R&D, while entering the development and production of active ingredients and Biotechnology.
At the same time, the company is committed to ensuring equality, diversity and inclusion in the working environment and has adopted -within this context- the Diversity Charter for Greece.
DEMO moves "Always Forward" driven by its corporate philosophy of providing quality and reliable pharmaceutical products, for everyone.
Learn more at www.demo.gr
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