Raquel Rossiter

QA Manager at inglasia pharma solutions
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Contact Information
us****@****om
(386) 825-5501
Location
Reading, England, United Kingdom, GB

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Credentials

  • Epidemiology: The Basic Science of Public Health
    Coursera
    Mar, 2014
    - Oct, 2024
  • Genes and the Human Condition (From Behavior to Biotechnology)
    Coursera
    Dec, 2013
    - Oct, 2024

Experience

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • QA Manager
      • Nov 2021 - Present

      ► Assisting with implementation of GDP QMS for global freight forwarding client. ► Assisting with creation of a CSV framework► Supporting clients with day to day QA activities and quality event closure in readiness for MHRA GDP inspection ► Assisting with implementation of GDP QMS for global freight forwarding client. ► Assisting with creation of a CSV framework► Supporting clients with day to day QA activities and quality event closure in readiness for MHRA GDP inspection

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • QA Associate
      • Nov 2020 - Nov 2021

      ► Awarded two recognition awards voted for by interdisciplinary team colleagues► Working within the Quality operations team as QA lead on a range of IMP development and manufacturing projects► Review of quality docs including SOPs, Quality technical agreements, risk assessments, batch records and change control ► Review and approval of validation activities for equipment and utilities► Preparation of client Quality Agreements► Completing batch record review and compiling documentation to facilitate QP release ► Management of CAPAs, investigations, LIRs, Deviations and Risk Assessments► Review and approval of analytical documents► Conducting QA spot checks of GMP areas

    • India
    • Financial Services
    • Quality Assurance Specialist
      • Jan 2019 - Nov 2020

      ► System administrator of the electronic document management and training system, MasterControl, providing ad-hoc support to all users► Assisted with the execution of a CSV project to upgrade and simplify the system► Supported as backroom lead for a successful initial MHRA GDP audit, and a successful maintenance MDASAP audit► Involved in deviation investigation, carrying out root cause analysis, risk and CAPA management► Development and deliverance of GxP and quality specific system training to colleagues► Management of the Approved Supplier List,

    • QA Associate
      • Sep 2017 - Jan 2019

      ► Devised and implemented a system improvement project for the storage, transfer and shipping of customer samples which greatly reduced time wasted managing the samples► Established new signage and shelving locations for archive boxes to improve organization, reduce time spent searching for boxes, and improve traceability of documentation within the archive room.► Issuing of batch records and other essential GMP documentation for manufacture to tight deadlines ► Devised and implemented a system improvement project for the storage, transfer and shipping of customer samples which greatly reduced time wasted managing the samples► Established new signage and shelving locations for archive boxes to improve organization, reduce time spent searching for boxes, and improve traceability of documentation within the archive room.► Issuing of batch records and other essential GMP documentation for manufacture to tight deadlines

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Quality Assurance Officer
      • Feb 2016 - May 2017

      ► Management of the Product Quality Complaints system - implemented an improvement project which reduced time taken for complaint closure► Maintenance of the SOP control system - ComplianceWire► GMP procedure reviewing, editing, writing and issuing► Administration of the change control, CAPA and deviation management systems► Supported staff from all departments with their QA actions in regular Quality Councils ► Management of the Product Quality Complaints system - implemented an improvement project which reduced time taken for complaint closure► Maintenance of the SOP control system - ComplianceWire► GMP procedure reviewing, editing, writing and issuing► Administration of the change control, CAPA and deviation management systems► Supported staff from all departments with their QA actions in regular Quality Councils

    • Quality Assurance associate (Temporary)
      • Sep 2015 - Feb 2016

      ► Review of batch packaging records ► Organization and archiving of batch records ► Maintaining the existing QMS and improvement of tracker spreadsheets to increase efficiency► Filing of quality event records ► Review of batch packaging records ► Organization and archiving of batch records ► Maintaining the existing QMS and improvement of tracker spreadsheets to increase efficiency► Filing of quality event records

    • United States
    • Manufacturing
    • 700 & Above Employee
    • Laboratory Technician
      • Jul 2015 - Sep 2015

    • United Kingdom
    • Transportation, Logistics, Supply Chain and Storage
    • 400 - 500 Employee
    • Customer Service Agent
      • May 2015 - Jul 2015

    • United Kingdom
    • Higher Education
    • 700 & Above Employee
    • Student Ambassador
      • Jan 2013 - Mar 2015

    • United States
    • International Trade and Development
    • 500 - 600 Employee
    • Sample Preperation Technician
      • Jun 2014 - Sep 2014

Education

  • Coventry University
    Bachelor of Applied Science (BASc), Biomedical Sciences, General
    2011 - 2015
  • Bracknell and Wokingham college
    2009 - 2011

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