Quality Assurance Operations Expert

At DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, Biotechnology is a key area of strategic growth and investment. The field of Biotechnology is transforming medicine and healthcare through the development of advanced biological products. DEMO continues to strengthen its capabilities in this field through significant investment in infrastructure, scientific expertise and talent.

Our biotechnology facility in Athens has now been completed, providing dedicated capabilities for biotechnology R&D, Quality Control and the development and future manufacturing of monoclonal antibody (mAb) products.

R&D activities for monoclonal antibodies are already underway, as we advance our biotechnology portfolio and prepare for the next stages of scale-up, technology transfer and GMP operations.

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 oversight of biotechnology manufacturing, QC/R&D, warehouse, facility and support activities, ensuring compliance with EU GMP, approved procedures and the Pharmaceutical Quality System.
• Acts as a senior QA subject matter expert, supporting the implementation and continuous improvement of the BIO Quality Management System.
• Reviews and/or approves deviations, investigations, CAPAs, OOS/OOT events and effectiveness checks, ensuring appropriate root-cause analysis, risk assessment and timely closure.
• Provides QA assessment and approval of Change Controls affecting processes, facilities, utilities, equipment, analytical methods, computerized systems, materials, suppliers and GMP documentation.
• Provides QA oversight of upstream and downstream biotechnology operations and reviews relevant manufacturing documentation, including master/batch records, instructions, logbooks, forms and in-process control records.
• Provides QA support and oversight to QC and GMP-relevant R&D activities, including analytical method qualification/validation and transfer, laboratory investigations, stability activities, specifications and equipment qualification.
• Reviews and/or approves qualification and validation strategies, protocols and reports for facilities, utilities, manufacturing and laboratory equipment, cleaning, processes, analytical methods and transport/storage activities.
• Reviews, prepares and/or approves controlled GMP documentation, including SOPs, policies, protocols, reports, Quality Agreements, risk assessments and master documents.