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Divisional QMS SME

Posted 17 April by Dechra Pharmaceuticals PLC
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Salary icon Competitive salary
Location icon Lostock Gralam , Cheshire

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Summary

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 2500 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

As part of the Business Transformation plan, DM&S is developing harmonised, streamlined and GMP complaint quality processes that can be used at divisional and site level. It is also investing in a fully validated digital quality management system (Veeva) to improve the control and visibility of our quality processes and increase operational efficiency. The purpose of this role is to develop, author and implement Standard Operating Procedures (SOPs), guidance documents and other documents as required to facilitate the introduction of the Veeva eQMS at the divisional level.

This role has line management into the Compliance team which is responsible for the Global Quality Documentation system but takes direction and work closely with the Veeva Project Team lead by the Head of QMS.

The job holder will work with the Divisional Quality Team and the Veeva Business Owner to develop and write divisional processes and procedures in support of the Veeva implementation at the Divisional level.

This role can be done remotely or on a hybrid basis from our Northwich office.

Travel may required in the role.

Main Responsibilities

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

  • Work with the Divisional Quality Team to write Procedures and Guidelines to implement Dechra's QMS at a divisional level, specifically Change Control, Deviation, CAPA, Continuous Improvement, and Quality Risk Management (QRM) to ensure Veeva can be deployed at the Divisional level
  • Work with the QMS Deployment Lead regarding training all stakeholders in the divisional business practices.
  • Help support the generation of KPI by preparing Veeva SOPs and work instructions to support the Divisional Management review process.
  • Working with the Veeva Deployment Lead and Head of QMS, perform process confirmation (effectiveness checks) of the deployed eQMS systems at the sites post-Hypercare.
  • Support wider quality teams with
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:

  • Significant experience in the pharmaceutical industry, preferably the veterinary pharmaceutical industry
  • In depth knowledge of relevant regulatory authority guidelines , including UK/EU/US GMPs and GDPs and ICH 10
  • A sound understanding of the principles of Quality Risk Management, including ICH Q9
  • A strong track record of establishing / improving processes and systems which facilitate the delivery of activities to the required quality and regulatory standards
  • Strong leadership skills and the ability to challenge, influence and build consensus
  • A proven ability to be able to manage changing situations with efficiency, calmness and purpose
  • Effective technical and non-technical communicator
  • Degree in Chemistry, Pharmacy or other related program is desirable but workplace based knowledge will also be taken into account

Reference: 52488719

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