Beschreibung

In this role, you will ensure product quality by preparing reviews, managing regulatory documentation, and participating in audits. You will collaborate with experts to streamline processes and support product launches, making a significant impact on quality assurance.

Anforderungen

• •University degree in technical/scientific discipline such as biochemistry, chemistry, engineering, or equivalent
• •At least 3-5 years of experience with manufacturing in the biotechnology and/or pharmaceutical industry
• •Experience in writing and/or reviewing eCTD licenses (quality - module 3)
• •Experience with the regulatory affairs framework (CMC)
• •Good knowledge of FDA, EMA, ICH regulations and quality system standards
• •Experience as a change owner or project leader
• •Knowledgeable in GMP inspections and management of regulatory/quality standards
• •Fluency in English and French
• •Knowledge/Experience with quality tools such as Trackwise 8, Veeva, eCTD viewer
• •Good knowledge of FDA, EMA, ICH regulations and quality system standards
• •Experience as a Change owner or project leader
• •Knowledgeable in GMP inspections and management of regulatory/quality standards
• •Work in a controlled environment requiring special gowning and protective clothing
• •Need to remove all make-up, jewelry, contact lenses, nail polish, and/or artificial fingernails
• •Work around chemicals such as alcohol, acids, buffers that may require respiratory protection

Aufgaben

• •Prepare Product Quality Reviews (PQR) annually for products manufactured at the Neuchâtel facility
• •Review global release specifications and implement updated versions for Neuchâtel products
• •Participate in GMP tours to ensure inspection readiness
• •Manage and prepare documentation for regulatory submissions and major change projects
• •Prepare and review documentation for change controls, audit observations, and regulatory agency inquiries
• •Support and write responses to regulatory agency questions, collaborating with Subject Matter Experts as needed
• •Assist in the preparation of inspections and required documents
• •Participate in audits and inspections as required
• •Help define strategies for responses to health authority questions as part of the quality matrix team
• •Update inspection records in TrackWise when necessary
• •Propose initiatives to improve and streamline quality tasks
• •Assist in the preparation and review of quality documentation as needed
• •Participate in Quality Council meetings as necessary
• •Support coordination of site Key Performance Indicators (KPIs)
• •Participate in project teams based on expertise and project focus
• •Engage in product launch activities
• •Identify opportunities to enhance quality processes
• •Collaborate with global Quality Product Leads and Regulatory Affairs partners

Tools & Technologien

Benefits