Quality Assurance Operations Expert - Biotechnology

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.
• Acts as a key QA lead for inspection and audit readiness, taking an active role in regulatory inspections, customer/internal audits and supplier audits, including coordination of requested documentation and evidence, preparation of responses and CAPAs, and follow-up of agreed actions.
• Supports supplier and material quality activities, Quality Risk Management, Quality metrics/trending and continuous improvement initiatives.
• Provides GMP and Quality guidance, supports knowledge sharing across BIO teams and works closely with Manufacturing, QC, R&D, Warehouse, Engineering, Validation, Regulatory Affairs, Supply Chain and IT.
• Participates in cross-functional projects, including technology transfer activities, and exercises independent Quality judgement within the assigned level of authority.
• Delivers training within the team and, where applicable, to relevant cross-functional stakeholders.

Requirements

• Bachelor's degree in Biology, Biotechnology, Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Biomedical Sciences or another relevant Life Sciences/Engineering discipline. A postgraduate degree is considered an advantage.
• Minimum 7 years of relevant experience in the pharmaceutical or biotechnology industry, including substantial experience in GMP Quality Assurance and/or GMP operations. Experience in biologics/biotechnology manufacturing is strongly preferred.
• Demonstrated experience in technology transfer activities for pharmaceutical or biotechnology products, including process and/or analytical method transfer, transfer documentation, risk assessment and qualification/validation activities.
• Strong practical experience with deviations, investigations, Risk Assessments, CAPA, Change Control, Quality Risk Management and qualification/validation activities.
• Strong knowledge of EU GMP requirements and Pharmaceutical Quality Systems, with a good understanding of biotechnology/biologics manufacturing processes.
• Strong investigation, root-cause analysis, risk-based decision-making, problem-solving and technical document review skills.
• Ability to work independently, manage multiple priorities, exercise sound Quality judgement and collaborate effectively across functions.
• Very good command of English. Experience with electronic Quality, ERP and document management systems is considered an advantage.

Benefits

The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.