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Validation Specialist Job in Skipton Recruiting by Dechra

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Validation Specialist

🔖 Full Time

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Job Introduction

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

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

Dechra Pharmaceuticals are looking for an experienced Validation Specialist to join our global manufacturing site.

You will be the site lead for equipment, facility and utility validation to ensure regulatory compliance to established internal and external criteria.

Your duties will also make you responsible for developing the overall validation program within Dechra and providing guidance in establishing and maintaining cGMP compliant processes and site validation master plan. The role expects you to offer support to the technical, QC and operations teams with validation as required, particularly with implementation of new equipment.

The role will be based onsite at our Skipton location.

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:

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

Represent the company at customer and regulatory inspections (including VMD & FDA) and respond to questions

Ensure the Quality Systems metrics associated with Validation are maintained within agreed limits according to the site performance indicators

To perform other duties as may be reasonably requested and agreed with Senior Management

Support quality and productivity improvements

Contribute towards reducing product cost movements through the improvement of production utilisation and ensuring continuous improvement

Support in ensuring department outputs (KPI’s) are met and that established cGMP quality standards are adhered to at all times

Take reasonable care of both your own health and safety and that of others who may be affected by your acts or omissions, ensuring all company safety requirements are followed and all relevant legislation complied with, raising concerns and reporting any incidents or suggestions to your line manager

Ensure the workplace environment is maintained to a high standard of cleanliness and tidiness, and complies with company and legislative standards at all times

Ensure all waste is disposed of safely and in line with company processes, recycling wherever possible

The Ideal Candidate

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:

Experience of validation and qualification in the Pharmaceutical industry

Proven industry experience from a highly regulated GMP manufacturing/packing facility, either from the Pharmaceutical or similarly regulated industry/environment

Strong technical writing skills with a thorough understanding of good documentation practice

Ability to prioritize multiple tasks/functions effectively in a global, multi-site organization

Work collaboratively across a matrixed organization in a fast-paced manufacturing environment with the ability to communicate effectively both with the team, and with other areas

A working knowledge of continuous improvement activities and ability to manage time and workload effectively is a benefit

Good knowledge and understanding of Health & Safety compliance

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What is the work culture like at Dechra?

The work culture at Dechra must adhere to the Ethics of Work Culture as described in the Ethical framework of the UN Charter. You can gain more insights into their local workplace environment by exploring their jobs Dechra and also by visiting their official website through Google.
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