QC Project Team Leader

6 days ago

Skipton, North Yorkshire, United Kingdom Dechra Full time

Job Overview

Dechra, a leading global specialist in veterinary pharmaceuticals, is seeking a highly skilled QC Project Team Leader to join our Skipton site. 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 products, ensuring compliance with GMP regulations and company standards.

Key Responsibilities

  • Lead a team to deliver project objectives to expected timelines
  • Coach and mentor team members to develop relevant skill sets
  • Review specifications to ensure non-value adding tests are removed from the finished product specification
  • Redevelop tests to run more efficiently, better supporting the testing of high numbers of samples at one time
  • Redevelop tests to run on more efficient equipment
  • Write development protocols and reports
  • Perform validation and verification, including producing protocols and reports
  • Submit updated test regimes to regulatory authorities, including justification of specification
  • Manage updates to methods, specifications, and test records in Quality Control
  • Lead change controls
  • Utilize technical knowledge to train and coach project analysts to enable them to support project goals
  • Liaise with MS&T, QC Support, Regulatory, and QA
  • Act 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 troubleshoot 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 consistent with cGMP, cGLP, and Health & Safety within a pharmaceutical laboratory environment

Requirements

  • Education to HNC/D level in a relevant scientific subject or significant job-specific experience
  • 3 years' experience working in method development in a pharmaceutical GMP environment
  • GMP regulations for products produced, tested, and marketed within the UK, EU, and US
  • Knowledge of specification setting
  • Computer literate, with an attention to detail (inc. formatting) and clarity
  • Effective and tailored communication
  • Influencing
  • Problem-solving
  • Pragmatism
  • Attention to detail

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

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