infrastructure for others to build on via Science Foundry. The QARA GMP Engineer will serve as the manufacturing and production... expert within our Quality and Regulatory Affairs team, where each team member brings both quality and regulatory knowledge...
infrastructure for others to build on via Science Foundry. The QARA Engineer drives the successful regulatory compliance...'s innovative product lines. This position blends quality, regulatory, and project management expertise with agile methodologies...
operations expert within our Quality and Regulatory Affairs team, where each team member brings both quality and regulatory... knowledge but specializes in a specific domain. This role focuses on ensuring the regulatory and quality compliance of clinical...
, insight and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements.... Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016. Solid communication...
, insight and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements... of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016. Solid communication and interpersonal skills...
of management, peers and key stakeholders, including timely escalation of quality issues. Participate in, or lead, the completion... of CAPA projects, assuring compliance, quality and timeliness of records. Collaborate with cross-functional teams using...