QCPD Specialist

Alvotech is looking for a QA professional supporting combination product and devices R&D and Design Control activities, responsible for the review and approval of quality documentation throughout the product development lifecycle, ensuring compliance with 21 CFR Part 820 and ISO 13485 requirements. Partners closely with R&D teams to provide quality guidance, promote compliance, and support the effective execution of quality procedures. Contributes to the development and continuous improvement of the Quality Management System, authors and reviews quality procedures, leads cross-functional quality initiatives, supports regulatory inspections and health authority interactions, and independently manages quality improvement projects.

Specifics of the role:

• Execute QA review and approval of various quality related documents generated by CPD R&D during all stages of device design control (DHF, risk management files, and other associated documentation) in a 21 CFR Part 820/ISO 13485 compliant QMS.
• Collaborate with R&D partners in daily compliance activities and coach in executing quality related procedures.
• Contribute to, author, review and approve procedures, and other supporting documents related to CPD processes.
• Contribute as required in design, deployment, and improvements of the phase appropriate Quality Management System (QMS).
• Routinely leads cross functional projects and performs variety of tasks of variable complexity.
• Contribute as required in internal and health authority inspections and any other interactions with regulatory agencies.
• Execute Quality projects independently as assigned.
• Subject matter expert within field (device design control).
• Main scope is internal CPD projects requiring expert QA support
• Quality oversight and support of design control development and validation activities across the entire combination product development lifecycle.
• R&D Quality compliance SME responsible in all phases of the device design control process from concept/feasibility/planning through commercial product lifecycle management
• Application of phase appropriate cGMP design control across the product development lifecycle within the R&D, Quality Management System (QMS), with a specific focus on injectable biosimilar Combination Products and Devices.
• High level of independence and accountability for QA project support according to CPD timelines.
• Performs variety of tasks of variable complexity.
• Participates in large strategic or developmental projects.
• Challenges and decisions faced in the role are often non-precedent.
• Can have impact on large, important projects.

Education and Experience: 

• Bachelor‘s/Master‘s degree in chemistry, biochemistry, biotechnology or equivalent. 
• Minimum 5 -10 years' experience in a quality assurance function supporting devices and /or 
  combination products 
• Strong working knowledge of ISO 13485/FDA 21 CFR Part 4 and Part 820. 
• Proficient in Quality system processes such as CAPA, Change controls, Investigations, and 
  document management, etc. 
• Knowledge of physical device testing and characterization methods. 
• Knowledge of physiochemical/bioanalytical methods is a strong plus 
• Thorough understanding of regulatory GxP requirements and risk management principles 
• Experience in supporting regulatory audits including FDA and EMA is highly desirable.
• Prior experience of using Veeva Quality system is a strong plus.Alvote