Why Dechra? Thank you for checking out our vacancy, we're delighted you want to learn more about joining Dechra.
Read all the information about this opportunity carefully, then use the application button below to send your CV and application.
A career at Dechra is different. Sure, we're a growing global company with a presence in 27 countries but our purpose is simple - to achieve the sustainable improvement of animal health and welfare globally.
If you want to be part of a team that invests in your future and ensures you have the support to reach your full potential and thrive, please read on.
The Opportunity
The Lead Auditor is responsible for conducting independent appraisals of quality and compliance systems, procedures and activities relating to GMP/GDP, in order to determine their effectiveness in meeting requirements in a risk-based manner and ensuring Dechra management are informed of the compliance status and any significant issues.The position is responsible for audits of Dechra manufacturing and distribution sites, contractors, and other audits where a high level of skills and experience is required. Audits are conducted in accordance with local and international regulations/guidelines and company quality standards to assure compliance with cGMP's/cGDPs. The incumbent possesses good audit skills and specialised knowledge in one or more different areas e.g. sterile manufacture, API's, excipients, and packaging etc.
Role Responsibility
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
* Conduct independent appraisals of quality and compliance systems within manufacturing settings.
* Performs domestic, regional and international (subject to experience) audits of suppliers of chemicals, packaging components, finished drug products, and contracted services. Audits are conducted in accordance with cGMP's, ISO Standards, IPEC, ICH Q7A and company procedures as applicable.
* Participates in scheduled or unscheduled cGMP audits of internal Dechra Operational departments to ensure compliance to cGMP's and Dechra standards.
* Provide clear and scientifically/technically justified interpretations and support for any audit findings and proposed corrective and preventive actions.
* Liaise directly with local Dechra and/or regional and global senior management, where necessary, to ensure issues are understood and proposed actions are acceptable.
* Interpret and apply cGMP regulations and expectations.
* Proven written and oral skills with experience working in cross-cultural settings.
* Initiate and maintain close contacts with regulatory agencies and/or industry/professional organizations to keep aware of trends and initiatives in quality assurance, GMP compliance, and inspections.
* While maintaining independence, work closely with other QA colleagues to assure common understanding of developing interpretations of cGMP.
The Candidate
Here at Dechra we pride ourselves on being an inclusive employer. We know that individuals' unique background and experience can bring a wealth of variety and expertise to our global workforce. For this role, we're particularly keen to hear from those who have/are:
* 2 to 5 years' experience in a QA environment including audit experience
* Dechra business language is English
* Self-directed and highly motivated team player with solid organizational capabilities
* Cross-cultural awareness and sensitivity
* Excellent written and verbal communication skills, with an ability to manage stressful and confrontational situations to positive outcomes
* Proven ability to continually refresh cGMP interpretation and application through self-study and external involvement with industry groups
* Solid knowledge of modern quality systems, risk assessment, corrective and preventive action development and execution, and other evolving principles across the global compliance arena.
* Ability to motivate, coach and teach others
* Overseas auditing experience particularly in Europe or the US
* Experience in other GXP areas (GLP,GCP)
* Bachelors degree in a scientific discipline
* IRCA accredited PQMS Lead Auditor (preferred but not essential)
Additional Information:
Occasional global travel may be required with this role.
This role is remote and can be based in the UK or Europe
What we can offer you:
33 days annual (inclusive of Bank Holidays)
Holiday purchase scheme
Healthcare
Employee Assistance Program
Life Assurance
8% Employer Pension Contribution
Enhanced Family Leave
Bonus (discretionary)
Discounted Pet Food
About the Company
If a career at Dechra has piqued your interest, find out more at Dechra careers.
Dechra is a growing, global specialist in veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
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 could be suitable, and we encourage you to keep an eye on our careers site. We value diversity within our global workforce and encourage an inclusive culture.
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