Claire Miller

Currently, I am a technical lead for a Validation team that concentrates on Cleaning Validation, CCI Validation and Filter Validation. Previous role in the team: As an SME in the Cleaning Validation team my many responsibilities which included; execute all validation runs on all washer parts and tanks in the sterile Grade D and Grade C areas, scheduling these activities ensuring they are executed as per the site validation and re-validation strategy. Writing technical papers and justification documents which the site validation strategy is based on. Alongside this I author, review and approve cleaning validation study protocols and the corresponding summary reports, in support for products currently being manufactured and in support of new product introduction. This includes the qualification of equipment cycle development, initial validation, cross-qualification and re-validation. I am the visual inspection SME on site for all cleaning activities. I have been working in MSD Carlow since I graduated in 2014 with a Second Class Honours Degree specialising in Biology from the National University of Ireland in Maynooth. I also have three summer's experience in internships previous to that and so have gained a lot of experience in this industry. Some other experience I have gained include: • Acid washing glassware used for cleaning validation and verification runs containing needles. • Aid in the validation of Controlled Temperature Units. • Aid in Recovery studies for new products being introduced. • Aid in the validation of Shipping Processes. • Implement the 5S standard within the Technical Engineering Laboratory, including the ownership of a 5S'd area within the Tech Eng Lab. I was also the sole trainer on site who prepares and provides all training needed for cleaning validation/verification runs. This included Visual Inspection, Swab Sampling (TOC/ICP/HPLC), and Rinse Sampling. This training also includes running of the TOC analyser in the Tech Eng Lab which I am fully trained and experienced in. I have experience in manual inspection of vials and syringes (product, media and WFI) as part of executing distribution studies for shipping validation.