Stability Associate

You will maintain and co-ordinate the Dechra Skipton GMP-compliant stability programme for veterinary medicines in compliance with VICH and product licence requirements (with the support of the Stability Specialist).

You will provide technical and administrative input into the design, execution, trending and reporting of stability data. Other responsibilities of the role include; co-ordinating in-house/external stability testing capabilities/capacity and stability study control measures. Hands-on execution of analytical testing for stability samples is not within the scope of the role.

You shall enhance best practices and proactively contribute to a culture which is consistent with cGMP, cGLP and Health & Safety expectations within a pharmaceutical laboratory environment.

The day-to-day will involve routine and non-routine tasks. You'll be expected to control and maintain the stability management program, including:

• New sample requests (routine and ad-hoc)


• Full lifecycle management of samples, including their set-down, availability for testing and subsequent destruction


• Pull date management and sample retrieval


Additional roles and responsibilities may include:

• Samples submission to external testing houses


• Trend analysis, including the reporting of OOS/T results


• Author Stability Protocols and Reports


• Stability Cabinet / Chamber telemetry monitoring


• Collate and report KPIs and other quality-indicating metrics, as necessary


• Write, review and revise SOPs, as required


• Participate in Laboratory Investigation Reports (LIRs), raise and actively manage Deviations, Change Controls, CAPAs, Due Date Extension Requests and Effectiveness Reviews for related work


• Play an active part in the development of the department by constructively highlighting deficiencies and inefficiencies.


• Support the management team, as directed in the execution of their duties


• 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.


• In addition to the core responsibilities listed above, the jobholder may be required to perform other duties on an ad-hoc basis.


The Ideal Candidate

What do you need to bring to the table?
Whilst there will be no practical work involved in the lab, having experience as an analyst will be an advantage and will help you to interpret the data you're working with. You'll need to be a confident communicator when working with various other departments, but you'll need to be comfortable working alone in the day-to-day tasks of your role.


• Precision and focus


• Coaching


• Effective and tailored communication


• Problem-solving


• Pragmatism


• Attention to detail


• 2 years' related experience working in a Quality Control / Assurance or R & D department within a GMP-compliant environment (e.g. as a stability analyst and/or in a stability-related administrative capacity)


• A sound understanding of VICH guidelines, (GL3, GL4, GL5, GL45, GL51, GL58) ideally with hands-on experience of executing stability programs including reporting, monitoring, and assessing of trends


• GMP regulations for products produced, tested and marketed within the UK, EU, Japan and US


• Familiar with environmental, health & safety and regulatory standards.


• Computer literate established Microsoft Office user (Word, Excel), with an attention to detail (inc. formatting) and clarity Minimally, educated to HND level in a relevant scientific subject or possesses job-specific experience


• 
  
  Whether you're a well-established QC professional or have one to two years of industry experience within Quality Control/Assurance or R&D and looking for that next step in your career, our diverse and well-established team is looking forward to welcoming you!
  
  Dechra are a growing, global specialist in the world of veterinary pharmaceuticals. Our expertise is in developing, manufacturing, marketing, and selling 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 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. Main Responsibilities
  
  Due to the nature of our business, all successful candidates will be required to complete a basic DBS check (Disclosure and Barring Service check) before employment can commence, and at regular intervals during employment. This check will be paid for by Dechra. About The Company
  
  Our internal talent acquisition team reviews all applications received and we will get in touch if your skills and experience match what we're looking for. Should you not hear back from us within 28 days please don't be too disappointed - we may keep your CV on our database for any future vacancies which may be suitable and we encourage you to keep an eye on our careers site.
  
  For any questions or queries, please contact us at recruituk@dechra.com Package & Benefits
  
  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