quality assurance operations expert - biotechnology
Oct 8, 2026 · DEMO S.A. Pharmaceutical Industry
What you'll do
- Provide independent QA oversight of biotechnology manufacturing, QC/R&D, warehouse, facility and support activities.
- Support implementation and continuous improvement of the BIO Quality Management System.
- Review and approve deviations, investigations, CAPAs, OOS/OOT events and effectiveness checks.
- Assess and approve Change Controls affecting GMP processes, facilities, equipment, systems, materials and documentation.
- Oversee upstream and downstream biotechnology operations and review manufacturing documentation.
- Support QC and GMP-relevant R&D activities, including analytical method qualification, validation and transfer.
- Review and approve qualification and validation strategies, protocols and reports.
- Review, prepare and approve controlled GMP documentation, including SOPs, protocols, reports and risk assessments.
- Lead audit and inspection readiness, including documentation, responses, CAPAs and follow-up actions.
- Support supplier and material quality activities, Quality Risk Management, metrics, trending and continuous improvement.
- Provide GMP and Quality guidance and collaborate with cross-functional BIO teams.
- Participate in cross-functional projects, including technology transfer activities.
- Deliver training to team members and relevant cross-functional stakeholders.
Key requirements
- 7+ years' experience
- GMP Quality Assurance, EU GMP requirements & Pharmaceutical Quality Systems
- Deviations and investigations, CAPA, Change Control & Quality Risk Management
- Qualification and validation, Technology transfer & Biotechnology manufacturing processes
- Root-cause analysis, Problem-solving & Technical document review
- Audit and inspection readiness
- English language
- Biology / Biotechnology / Pharmacy / Chemistry / Biochemistry / Chemical Engineering / Biomedical Sciences / Life Sciences or Engineering
Benefits
- The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
About the job
As our biotechnology activities continue to expand, we are currently looking for an experienced QA Operations Expert to join our team and provide senior Quality Assurance support and oversight across BIO operations in Agios Stefanos. Main duties and responsibilities: - Provides independent QA…
About the company
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.
About the company
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.