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.