Group Project Leader

1 month ago

Skipton North Yorkshire, United Kingdom Dechra Pharmaceuticals Limited Full time

Summary
Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra

QC Project Team Leader
Site-based, Skipton
24-Month Fixed-Term Contract
08:00-16:30, Mon - Fri with every other Friday off (9 day fortnight)
Dechra are 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.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.
Package
So, what's in it for you?
Our QC team at Skipton have a healthy work culture and supports one another to meet our goals. We have a wealth of knowledge within the department and specialists in Quality, Technical and Analytical. You'll have a place where your knowledge will be valued, and you'll most certainly learn a few new things.
We expect you to grow in line with our company values while you work alongside some great individuals. You'll be offered a competitive salary in addition to:
~ 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

Main Responsibilities
So, what's the role?
Dechra Skipton is embarking on a major multimillion pound investment to introduce new granulation equipment and is looking to expand the QC Team to Support this. This will require all tablets and capsules to undergo process validation and associated stability testing in a short period of time.
To ensure this can be supported, you'll be tasked with leading 3 project analysts to optimise test regimes on the products.
Additional roles and responsibilities may include:
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 off 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.
In addition to the core responsibilities listed above, the jobholder may be required to perform other duties on an ad-hoc basis.
Ideal Candidate
What do you need to bring to the table?
We'll look to you to offer coaching and mentoring for the QC Project Analysts and provide expertise within Method Development. This is an exciting project with an opportunity to put your stamp on things, adding value to the QC function and the wider business.
The below skills/experience will also stand you in good stead:
~ Educated to HNC/D level in a relevant scientific subject or possesses 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

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