Quality Assurance Operations Expert - Biotechnology

About the role

DEMO SA, a major manufacturer of injectable pharmaceuticals, has completed its biotechnology facility in Agios Stefanos, which covers biotechnology R&D, quality control and the development and future manufacturing of monoclonal antibody products. As the company expands its biotechnology activities, it is looking for an experienced QA Operations Expert to provide senior quality assurance support and oversight across BIO operations.

Key responsibilities

• Provide 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.
• Act as a senior QA subject matter expert supporting the implementation and continuous improvement of the BIO Quality Management System.
• Review and approve deviations, investigations, CAPAs, OOS/OOT events and effectiveness checks, ensuring proper root-cause analysis, risk assessment and timely closure.
• Assess and approve change controls affecting processes, facilities, utilities, equipment, analytical methods, computerized systems, materials, suppliers and GMP documentation.
• Oversight of upstream and downstream biotechnology operations, including master/batch records, instructions, logbooks, forms and in-process control records.
• Support QC and GMP-relevant R&D, including analytical method qualification/validation and transfer, laboratory investigations, stability activities, specifications and equipment qualification.
• Review qualification and validation strategies, protocols and reports, and approve controlled GMP documentation such as SOPs, policies, protocols, Quality Agreements, risk assessments and master documents.
• Lead inspection and audit readiness, coordinate documentation and evidence, prepare responses and CAPAs, and follow up on agreed actions.
• Support supplier and material quality, Quality Risk Management, quality metrics and trending, and participate in cross-functional projects such as technology transfer.
• Deliver training within the team and share knowledge across BIO teams.

Required profile

• Bachelor's degree in Biology, Biotechnology, Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Biomedical Sciences or another relevant Life Sciences/Engineering discipline; a postgraduate degree is an advantage.
• Minimum 7 years of relevant experience in the pharmaceutical or biotechnology industry, including substantial GMP QA and/or GMP operations experience; biologics manufacturing experience strongly preferred.
• Demonstrated experience in technology transfer, including process and/or analytical method transfer, transfer documentation, risk assessment and qualification/validation.
• Strong practical experience with deviations, investigations, risk assessments, CAPA, change control and quality risk management.
• Very good command of English; experience with electronic quality, ERP and document management systems is an advantage.

Required skills

• Strong knowledge of EU GMP requirements and Pharmaceutical Quality Systems, with a good understanding of biotechnology/biologics manufacturing.
• Investigation, root-cause analysis, risk-based decision-making, problem-solving and technical document review.
• Ability to work independently, manage multiple priorities and collaborate across functions.

What we offer

• Competitive remuneration.
• Continuous learning and development opportunities.
• A friendly and challenging working environment.