Divisional QMS SME

4 weeks ago


Northwich Cheshire, United Kingdom Dechra Pharmaceuticals PLC Full time

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.
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. 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.
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
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
Degree in Chemistry, Pharmacy or other related program is desirable but workplace based knowledge will also be taken into account


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