Hannah Blythe

Experience

• 

  Sciantec Analytical Services

  Dec 2004 - Nov 2007

  Analytical Chemist

  Work involved the analysis of animal feeds, raw materials and other food additives. I worked on the chromatography section, where my responsibilities included HPLC and GC analysis of samples for medicinal products and vitamins.

• 

  Reckitt

  Dec 2007 - now

  Compliance reviews of registered information. Responsible for updating and creating dossier sections and TDS documents to ensure compliance with current license requirements and monographs. Regular communication with regulatory, supply, category and HME teams to align actions and responsibilities and to ensure that the updates are suitable for all involved. Time management and organization are key skills as it is common to be working on multiple products/formulations all with different deadlines. The role also involves line management responsibilities for a RegEx assistant. Show less The role involved management of the finished products analysts and senior analysts (19 direct reports). I was responsible for regular performance reviews and development for each of these analysts. My day to day responsibilities included; • prioritization and delegation of work in line with changing customer service demands, taking ultimate ownership by feeding back to the business with expected timelines for release and re-prioritizing where needed. • Checking and approval of analytical results to ensure timely release of products.• Approval of out of specification investigations, change controls, NCR’s and deviations.• Providing support and information to customer service, release for sale and manufacturing functions.• Providing cover and support for the QC manager where needed• Review, update and training of SOPs, including authoring and approval on TDSOther responsibilities;• Participation in continuous improvement, most recently I led a small CI group to develop new training packages for QC.• Communicating performance against KPI’s via monthly report• Recruitment interviews.• Assisting in conducting internal audits and acting as a key contact and host as necessary when auditors visit the lab.• Creation and validation of chromeleon reports as necessary for compliant calculation of results Show less

  • Regulatory Operations Manager, Medicines, Post Launch

    May 2024 - now

  • Global regulatory manager

    Nov 2022 - May 2024

  • Senior Regulatory Affairs Associate

    Feb 2020 - Nov 2022

  • Regulatory Affairs Associate

    May 2019 - Feb 2020

  • Associate - R&D Operations - Analgesics, Cold & Flu

    Sept 2015 - May 2019

  • R&D RegEx Associate

    Jul 2013 - Sept 2015

  • QC Team Leader

    Feb 2012 - Jul 2013

  • QC Senior Analyst

    Dec 2007 - Feb 2012