Validation Specialist / Engineer
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 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
The Opportunity
- Site Lead for equipment, facility and utility validation to ensure regulatory compliance to established internal and external criteria.
- responsible for developing the overall validation program within Dechra providing guidance in establishing and maintaining cGMP compliant processes and site validation master plan.
- Support the technical, QC and operations teams with validation as required, particularly with implementation of new equipment.
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:
- Prepare, coordinate execution and review protocols and quality risk assessments associated with validation activities to a compliant, cGMP standard
- Support the site with validation activities as required.
- Responsible for initial and annual requirements such as thermal mapping and heat penetration studies, clean room qualification inc. non-viable particle counting, warehouse temperature mapping studies & drying oven qualification activities.
- Documentation and remediation of deviations resulting from validation/qualification studies.
- Prepare and update validation associated SOPs.
- Trouble-shoot and provide recommendation and solution for identified validation and qualification issues based on sound and knowledgeable analysis.
- Work with production and planning to schedule the necessary qualifications/re-qualification’s with minimal impact on the manufacturing schedule.
- Remain current on legislative, regulatory and technical changes within the industry.
- Manage the maintenance of the validation equipment in a qualified/calibrated state
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 hear from those who have/are:
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Experience of validation and qualification either from the Pharmaceutical or similarly regulated industry/environment
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Proven industry experience from a highly regulated GMP manufacturing/packing facility, either from the Pharmaceutical or similarly regulated industry/environment
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Strong technical writing skills with a thorough understanding of good documentation practice.
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Ability to prioritize multiple tasks/functions effectively in a global, multi-site organization.
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