Quality Specialist Operations

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 )