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Establish and lead a satellite team in Manufacturing Development Life Cycle Management for a pharmaceutical production site. Drive strategic activities to ensure seamless integration of new products without disrupting existing production. Maintain quality specifications, regulatory documentation, and drive a safe workplace culture. Coordinate with internal and external stakeholders to meet quality and safety requirements.
The Deviation Investigator-Writer II is responsible for investigating and writing deviations to the manufacturing process and other operational problems in API manufacturing. They lead investigations, collaborate with cross-functional teams, conduct root cause analysis, and implement corrective actions to ensure compliance with regulatory standards and quality principles. This role plays a key part in the Deviation Response Team and upholds quality priority principles within the organization.
The Manufacturing Area Specialist I position at Novo Nordisk involves supporting manufacturing operations with a focus on training, documentation, deviations, change control, and projects. Responsibilities include coordinating process and equipment improvements, reviewing quality records, generating deviation responses, driving investigations, and training technicians on processes and quality management systems. The role also involves liaising between production support and manufacturing, creating and revising documentation, conducting root cause analysis, incorporating process improvements, and supporting quality systems and Health Authority inspections.
