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QC Project Team Leader

2 months ago

Skipton, North Yorkshire, United Kingdom Dechra Full time

About the Role

We are seeking a highly skilled and experienced QC Project Team Leader to join our team at Dechra Skipton. As a key member of our Quality Control team, you will be responsible for leading a team of project analysts to optimize test regimes on our products.

Key Responsibilities

  • Lead a team to deliver project objectives to expected timelines
  • Coach and mentor team members to develop relevant skill set
  • Reviewing specifications to ensure non-value adding tests are removed from the finished product specification
  • Redeveloping tests to run more efficiently, better supporting the testing of high numbers of samples at one time
  • Redeveloping tests to run on more efficient equipment
  • Writing development protocols and reports
  • Performing validation and verification, including producing protocols and reports
  • Submit updated test regimes to regulatory authorities including justification of specification
  • Manage update to methods, specifications, and test records in Quality Control
  • Lead change controls
  • Utilising technical knowledge to train and coach project analysts to enable them to support the project goals
  • Liaising with MS&T, QC Support, Regulatory, and QA
  • Acting as subject matter expert in QC for Method Development in HPLC, UPLC, UV, Dissolution, Disintegration, Friability, Hardness, Loss on Drying, FTIR, Karl Fisher, and pH
  • Conduct laboratory investigations, protocol deviations and provide technical expertise to trouble shoot challenging methods
  • Author Risk Assessments for processes, procedures and systems to ensure risks are identified and appropriately managed, including mitigation via corrective and preventive actions (CAPAs), where appropriate
  • Abide by and champion the company's values (Dedication, Enjoyment, Courage, Honesty, Ambition) in all aspects of the role, including interaction with co-workers and third parties
  • Enhance practices and promote a culture which is consistent with cGMP, cGLP and Health & Safety within a pharmaceutical laboratory environment

About You

We are looking for a highly skilled and experienced QC Project Team Leader who can lead a team to deliver project objectives to expected timelines. You will have a strong background in method development in a pharmaceutical GMP environment and be familiar with GMP regulations for products produced, tested and marketed within the UK, EU and US.

What We Offer

  • A competitive salary
  • Average 36-hour working week (with a day off every other Friday)
  • 22.5 days annual leave + Bank holidays
  • Option to buy a week's holiday each year
  • 8% Employer Pension Contribution
  • Free access to the Headspace App
  • Employee Assistance Programme
  • On-site parking
  • Volunteering days
  • Company events