QC Project Team Leader
5 days ago
Job Title: QC Project Team Leader
Job Summary:
We are seeking an 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 products and ensure compliance with regulatory requirements.
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 which is 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 Dechra:
Dechra is a growing, global specialist in the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing, and sales of high-quality products exclusively for veterinarians worldwide. It's a great time to join our modern Skipton facility as further investment for the Skipton site means that we're in an exciting period of positive change for the business.
How to Apply:
Please submit your application, including your CV and a cover letter, to [insert contact information]. We look forward to hearing from you.
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