DEMO S.A. Pharmaceutical one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a high caliber Head of QA in our QA Operations – Lyophilized Products department in Kryoneri.
Scope of the role is the monitoring of the quality system to ensure compliance of the manufacturing operations with current Good Manufacturing Practices and in-house QMS.
Responsibilities
- Guide, coach and manage the performance of a skilled team of scientists
- Coordinate and support quality investigations performed by his/her dept
- Follow-up on Deviations, Complaints, Change Management, CAPAs and other Quality issues in the field of authority
- Reviews protocols and reports of the validation studies relevant to manufacturing activities, APQRs etc
- Reviews Site Quality Documentation, eg VMP
- Participates in activities for new products’ initiation on behalf of Quality dept
- Design and lead the implementation of cGMP requirements and company’s QMS on establishment of new production lines for injectable drug products
- Review of standard operating procedures (SOPs)
- To closely monitor the production activities
- To collaborate with other departments of the site, such as Manufacturing, Technical, QC etc, to align activities and ensure compliance
- Coordinate and/or participate in on-site audits as host, post-audit follow-up actions
- Ensure compliance with EU-GMP regulations
- BSc Degree in Biology, Chemical Engineering, Chemistry or Pharmacy. MSc Degree in Quality Management or relevant field will be considered an asset.
- Minimum 2 years of experience in similar Quality Assurance role in Pharmaceutical Industry.
- Exposure in authorities’ inspections (PIC/s, USFDA) will be considered as asset.
- Fluency in Greek & English
- Computer literacy
- Ability to work creatively, analytically & synthetically with attention to detail
- Self-motivated & results oriented with ability to cope with strict timelines
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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