Job Description
Product quality and patient safety are at the center of what we do. As part of the Quality Assurance organization, the NPI QA Manager supports new product introductions, technical transfers, and quality oversight activities to ensure compliance with GMP standards, internal procedures, and global regulatory requirements.
Responsibilities
- Lead and coordinate Quality Assurance activities related to New Product Introduction (NPI) to ensure compliance with company standards and regulatory guidelines.
- Ensure compliance with established internal specifications, standard operating procedures (SOP) and government regulations.
- Coordinate and manage complex deviations, task forces and communication to ensure compliant release system for corresponding market.
- Act as a key QA contact for interactions with regulatory authorities (Swissmedic, FDA, etc.) to ensure timely product release.
- Support submission of test samples, certificates and...