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QMS Specialist

  • TFS
  • Full time
  • United Kingdom
  • 10/02/2021

The QMS Specialist is a member of the TFS Quality & Compliance and works closely with and reporting to the Quality Systems Director to ensure the efficient management of all aspects of the QMS including training, audit and legal.

Key responsibilities:

  • Support work related to the development, implementation and daily management of TFS Quality Management System (QMS) to ensure continuous quality improvement and compliance with laws/regulations
  • Quality Control (QC) and load all QMS documents to MasterControl and work with the training team to release training
  • Prepare and update the flowcharts within Standard Operating Procedures (SOPs) and other QMS Documents
  • Track and manage QMS Document revisions
  • Load and manage external purchased standards within MasterControl
  • Maintain users within MasterControl, resetting eSig passwords as required
  • Assist users to enter Quality Issues and SOP Deviations in MasterControl and manage the assignment of risk assessments and Corrective Action Preventative (CAPA) as appropriate
  • Prepare the month reports for Quality Events and training to send to appropriate staff
  • Prepare month metrics according to the Key Performance Indicators (KPIs) / Quality Performance Indicators (QPIs)
  • Support TFS Training department with administrative tasks, i.e. document archiving, training set-up, tracking etc.
  • Work with the audit and risk management team to assist staff members who are performing all types of internal and external GxP audits according to TFS policies, SOPs and regulatory requirements
  • Maintain and version control the standard audit presentations
  • Maintaining and version control the list of TFS Inspections and external audits
  • Enter all external audit and inspection findings and associated information into MasterControl
  • Administrative assistance to auditors in activities associated with audits – i.e. backroom support for TFS audits and inspections
  • Participate in internal department meetings as required and liaise with other departments as necessary
  • Coordinate presentations for projects, meeting materials, agendas, and meeting minutes
  • Support QPI and metrics when needed
  • Delegated for other tasks and activities by Quality Systems Director and other Directors within Q&C within scope of experience

  • Support TFS legal department with administrative tasks
  • Provide MasterControl assistance to all staff as needed, providing written documentation when identified as required

Requirements

  • University/college degree or equivalent industry experience
  • Good planning, organisation and problem solving abilities
  • Fluent in English, both written and verbal
  • Awareness of the clinical trials area / pharma industry, including knowledge of GxP environment
  • MasterControl experience preferred
  • Highly-analytical professional with strong attention to detail
  • Pro-active, recognizing and anticipating issues, addressing problems and developing solutions
  • Demonstrated ability to multitask, prioritize, and complete objectives
  • Excellent oral and written communication skills
  • Advance user of MS Office applications

Benefits

  • Private Health Coverage
  • Corporate Pension Plan
  • Life Insurance
  • Global General Liability Insurance
  • Global Travel Insurance
  • Home-based Allowance
  • Internet reimbursement
  • Flexible working schedule

About TFS

We believe that a company with ethical and transparent values has a better chance of attracting skilled employees and building long-term relationships.

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