QC Senior Analyst - Reference Standards
Job Introduction
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.
Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleague 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
The Opportunity
- Ensure a compliant and robust process is in place for the management of analytical references standards throughout their lifecycle, including:
- Ordering (internal and external sourcing)
- Management of stock levels and ensuring availability
- Administration of the Standard Management System
- Analysis and Certification
- Destruction and disposal
- Develop the above processes in line with regulatory expectations (current and anticipated).
- Proactively influence the QC management team regarding the adoption of ‘best practices’ to improve compliance and bring about efficiencies.
- Support ad-hoc investigations and provide technical support and expertise, as necessary.
- Undertake Laboratory Investigation Reports (LIRs), Deviations, Change Controls, CAPAs, Due Date Extension Requests and Effectiveness Reviews for related work.
- Act upon excursion notifications from the Environmental Monitoring System that have the potential to impact analytical standards.
- Reconciliation and completion of end-user declarations, in line with regulatory requirements, for Controlled Drug standards.
- Support the QC Compliance Manager, as directed in the execution of their duties.
- Author Risk Assessments on an ad-hoc basis for processes, procedures and systems to ensure risks are identified and appropriately managed, including mitigation via corrective and preventive actions (CAPAs), where appropriate.
Role Responsibility
The Challenge
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Ensure a compliant and robust process is in place for the management of analytical references standards throughout their lifecycle, including:
- Ordering (internal and external sourcing)
- Management of stock levels and ensuring availability
- Administration of the Standard Management System
- Analysis and Certification
- Destruction and disposal
- Develop the above processes in line with regulatory expectations (current and anticipated).
- Proactively influence the QC management team regarding the adoption of ‘best practices’ to improve compliance and bring about efficiencies.
- Support ad-hoc investigations and provide technical support and expertise, as necessary.
- Undertake Laboratory Investigation Reports (LIRs), Deviations, Change Controls, CAPAs, Due Date Extension Requests and Effectiveness Reviews for related work.
- Act upon excursion notifications from the Environmental Monitoring System that have the potential to impact analytical standards.
- Reconciliation and completion of end-user declarations, in line with regulatory requirements, for Controlled Drug standards.
- Support the QC Compliance Manager, as directed in the execution of their duties.
- Author Risk Assessments on an ad-hoc basis for processes, procedures and systems to ensure risks are identified and appropriately managed, including mitigation via corrective and preventive actions (CAPAs), where appropriate.
The Ideal Candidate
About You
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to here from those who have/are:
- At least 3 years’ experience working at an advanced level with analytical techniques (traditional and instrumental) in a pharmaceutical GMP environment.
- GMP regulations for the use and governance of analytical references standards for products tested and marketed within the UK, EU and US.
About the Company
About Your Application
All applications received are reviewed by our internal talent acquisition team 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
Dechra Pharmaceuticals PLC