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…)