Role: Scope of the project: Investigate and document Quality Assurance related deviations and escalate issues or prepare recommendations as appropriate to the Team Leader in a timely manner. Coordinate cross functional investigations in case of complex root causes and work closely with manufacturing, packaging and lab operations, supporting departments and/or third parties. Perform and/or evaluate investigations, root cause analysis, corrective and preventive actions and verify effectiveness in order to prevent recurring deviations. Report significant quality issues to regulatory agencies, according to local legislation (e.g. FAR and BPDR for US marketed products and other BOHs as applicable). Participation in operations, product and process teams and Daily Operations Review meetings. Perform trending analyses, define and/or evaluate necessary actions and verify effectiveness of these actions via trend reports. This position can be requested to participate in assignments defined by the Team Leader, Lead or Sr. Manager. The Quality Specialist Operations will respect the PGS vision, mission, values and behaviors to realize the PGS objectives related to quality, GMP, customer satisfaction, right first time and cost. Support continuous improvement initiatives in the department to improve processes and act on key KPI’s. Profile Bio Engineer, Pharmacist, Biology, Biochemistry, Biotechnology, Chemistry or Engineering or equivalent by working experience. Experience as Qualified Person is a plus. Preferably experience in a manufacturing, packaging or laboratory environment Preferably experience with quality investigations and release of biological products or vaccines Knowledge of NL/ENG Good analytical and problem-solving skills Good communication skills, verbal and in written Excellent documentation skills (technical report writing) Good time management and prioritizations skills Human interactions (diplomacy, convincing, assertiveness…)