Jobs in Fertigung, Inbetriebnahme und Qualitätswesen in Ludwigshafen

Assure proper integration and support of device regulations, drug regulations and, as appropriate, biologics regulations. Responsible for compliance with company policies and procedures. Perform design control activities: Mentor / lead product team members through the design process, providing guidance to assure optimal approach. Work closely with research organization to ensure potential product issues are identified and addressed in the design. Assure robust product vs. customer requirements. Ensure interfaces to drug development where appropriate. Ensure design control documentation (Traceability / Linkages) & design change control requirements are met. Assess the impact of a change on the safety, efficacy of the combination product / device. Analyze and justify the impact of cumulative changes. Perform 3rd party supplier management activities such as review and approval of 3rd party design control activities, assess supplier changes and ensure of appropriate balance between internal oversight actions and supplier controls, provide input to quality agreements, perform relationship development, and visit supplier sites. Support supplier audits as required. Partner with Third Party Vendors / Manufacturers / Laboratories to ensure that combination products / devices are in compliance with internal and Regulatory Agency standards. Risk Management: Global collaboration with R&D and Commercial Operations functions to identify and mitigate product risks to develop robust combination products and medical devices. Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation. Guide project development as team member in global and local product development teams for Combination Products to proactively and appropriately address quality-related issues. Advise internal business partners with regard to medical device / combination product regulations. Provide consultation & training on specific QA expertise to internal and cross-functional groups. Foster close global collaboration with R&D and Operations functions to identify and mitigate product risks to develop robust combination products and devices. Perform risk assessment of changes on safety and efficacy of Combination Products. Utilize risk control tools such as FMEA. Support the preparation of regulatory inspections and internal audits and represent GMP QA in inspections and audits as SME.