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…)