A Day in the Life of our Senior R&D Quality Officer…
• Support new product introduction and new equipment/ system introduction and ensure system, process, and all operations is in line with regulations and industry best practice, within required timelines. Ensure timely documentation review and product release is in line with regulatory requirements and to the required customer service levels
• Ensure all clinical customer complaints are logged, investigated and closed out in a timely manner all in accordance with cGMP’s and company procedures, in order to meet the objectives of the Quality Function
• Ensure software validation is carried out in compliance with site/ corporate policies and SOP’s
• Ensure R&D projects are in compliance with regulatory requirements and adhere to current US/ EU guidelines
• Provide the R&D department with Quality Assurance support for all clinical/submission batches, quality systems, IVBE studies, Device Design, Combination Products and support for all new product development project teams
• Provide the R&D department with guidance regarding clinical trial manufacture and new product development and introduction
Who we are looking for
Are you….
• Educated to Degree level in Pharmaceutical/Life Sciences
• Experienced in a Pharmaceutical, Medical Device or QA environment
• Experienced in Regulatory /Notified Body inspections
Do you have…
• In depth knowledge and understanding for interpretation of cGMPs and Regulatory requirements for Combination Products / Medical Devices / IMPs
• Experience with report writing, Project Management, Continuous Improvement and problem solving tools
• Understanding of production and laboratory systems to effect judgement decisions consistent with quality and business needs
• Knowledge and understanding of software validation / medical device requirements is desirable
