Sr. Quality Engineer / Investigation Owner

Opdrachtgever

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world.

Relevant BSc (HBO) degree with 7 to 10 years relevant experience in an investigation lead, Quality engineer or similar role within pharmaceutical industry, preferably in biologics manufacturing.
The levels of computer proficiency are intermediate level for MS office, routine level for data analysis, and specialist level for business applications.
Positive attitude, proactivity, decisive, and organized with an ability to work individually and in a team.
Stress-resistant, continues to work calmly under all circumstances.
High degree of accuracy and quality attitude.
Flexible, can deal with changing priorities.
Shows accountability by proactively addressing issues and taking responsibility for outcomes.
Analytical thinking: ability and dealing with complexity, asking questions, using data, using information and identify gaps and root causes of issues and think out of the box to develop a solution.
Prioritize tasks effectively to meet deadlines and ensure timely delivery.
Maintains effective alignment with stakeholders and establishes meaningful connections with customers.
Demonstrates strong coordination skills and is able to support supervisors and manager in workload management of the teams
Possesses strong communication abilities to facilitate clear direction, feedback, and collaboration among team members and stakeholders.
Adept at resource planning and workload distribution to maximize team efficiency and meet record deadlines.

Responsible for leading and managing quality investigations related to manufacturing processes, products, and systems.
Identify root causes of quality issues, coordinating corrective and preventive actions (CAPA), and ensuring compliance with internal standards and regulatory requirements.
Work closely with cross-functional teams to document findings, drive process improvements, and communicate results to stakeholders.
Oversee and review activities done by team members and check the thoroughness in risk assessment, root cause investigation, corrective and preventive actions defined in quality records.
Apply expertise knowledge of Quality requirements to support the handling of quality records.
Perform non-conformance investigations, including CAPA records and lead change controls (CC) for the operations unit from initiation through completion.
Review documentation associated with processes and activities for the Operations unit products.
Maintain procedures and applicable documentation and makes updates based on new or revised regulatory requirements, internal investigations, and audits.
Ensure compliant documentation and timely completion of quality records.
Initiate and implements risk mitigations and continuous quality improvement projects.
Perform regular GEMBA walks to observe and document adherence to GMP standards on the production floor.