As a Site Conformance Expert within our Quality Assurance team, you will be the vital link between operations and regulatory affairs, ensuring compliance across multiple production streams including Primary, Secondary, Quality Control, and Incoming Materials.
In this role you will play a key role in:
- Ensuring compliance with regulatory dossiers for activities related to Manufacturing Performance Units and Quality Control Departments, through variations and timely responses to health authority questions.
- Providing regulatory oversight within Manufacturing Performance Units and Quality Control Departments to maintain consistent alignment with evolving regulatory requirements.
- Analysing potential compliance gaps and developing effective mitigation strategies to prevent supply issues, delays, or recalls due to misalignment with regulatory files.
- Collaborating with cross-functional teams to implement and maintain quality systems that meet global regulatory standards across all production streams.
- Supporting continuous improvement initiatives to enhance compliance processes, documentation systems, and overall quality assurance performance.
