Quality Operations Specialist

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Applies expertise knowledge of Quality requirements to support the execution of Operations unit objectives

• Perform nonconformance investigations, including CAPA records and lead change controls (CC) for the operations unit from initiation through completion.
• Reviews documentation associated with processes and activities for the Operations unit products.
• Maintains 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.
• Initiates and implements risk mitigations and continuous quality improvement projects, under limited guidance.
• Supports with formal escalation processes to ensure visibility of risks associated with safety, product quality and regulatory compliance.
• Perform regular GEMBA walks to observe and document adherence to GMP standards on the production floor, identify areas for improvement, and collaborate with team members to implement corrective actions.

Cosa ci aspettiamo da voi

Minimum Qualification

• A relevant HBO degree with 3 years relevant experience.
• English B2 language level is required.
• 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.
• Previous experience with leading or providing significant guidance of change controls or quality investigations.
• Practices giving and receiving transparent and constructive feedback, learn from mistakes, and drive initiatives to achieve organizational and personal development goals.
• Coordinates team initiatives by providing clear direction and ensuring effective collaboration within the team.

Cosa puoi aspettarti da TMC

TMC is an international high-tech consultancy company that brings expertise to their clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster changing technological world. Our business cell lives by 3 principles:

• Best over biggest.
• Collaboration over individualism.
• Values and ethics over rules.

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