QC Project Team Leader
2 weeks ago
About Dechra
Dechra is a global specialist in veterinary pharmaceuticals, with a strong presence in the development, manufacture, marketing, and sales of high-quality products for veterinarians worldwide.
Job Introduction
We are seeking a highly skilled and experienced QC Project Team Leader to join our team at our Skipton facility. 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, ensuring compliance with GMP regulations and company standards.
Key Responsibilities
- Lead a team of project analysts 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
- 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
About the Role
This is an exciting opportunity to join our team and contribute to the success of Dechra. If you are a motivated and experienced professional with a passion for quality control, we encourage you to apply.
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