The Quality Project Associating services entails focussing on quality oversight and project support and has following responsibilities:
Investigate and document Quality Assurance related deviations and escalate issues or prepare recommendations as appropriate to the Team Leader in a timely mannerCoordinate cross functional investigations in case of complex root causes and work closely with manufacturing, packaging and lab operations, supporting departments and/or third partiesPerform and/or evaluate investigations, root cause analysis, corrective and preventive actions and verify effectiveness in order to prevent recurring deviationsReport 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 meetingsPerform trending analyses, define and/or evaluate necessary actions and verify effectiveness of these actions via trend reportsThis position can be requested to participate in assignments defined by the Team Leader, Lead or Sr. ManagerThe Quality Specialist Operations will respect the PGS vision, mission, values and behaviors in order to realize the PGS objectives related to quality, GMP, customer satisfaction, right first time and costSupport continuous improvement initiatives in the department to improve processes and act on key KPI's
Qualifications:Master's degree in a relevant scientific or engineering discipline, such as Industrial Engineering, Civil Engineering, Bio-engineering, or (Industrial) Pharmacy, or equivalent experience in fields like Biochemistry or BiotechnologyKnow-how of project management within the pharmaceutical or related industries, with a strong focus on GMP-regulated and aseptic environmentsStrong analytical and problem-solving abilities, excellent organizational skills, and a meticulous, accurate, and quality-conscious work approachStrong communication, interpersonal, and technical writing skills to effectively collaborate with cross-functional teams and external stakeholdersA perfect command of Dutch and good knowledge of English (written and oral) are required