Csv Consultant

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**

As part of a new global implementation of Oracle Cloud ERP system, provide Computer Systems Validation expertise and experience. Ensure the on time and compliant delivery of the validation aspects of the project.

Main Responsibilities
- Responsible for delivery the Computer Systems Validation aspects of the project in accordance with project objectives and timescales.
- Working collaboratively across the business to ensure that the validation is delivered on time and compliantly.
- Engage with vendors, third party service providers and internal IT functions in relation to qualification/validation activities.
- Transfer of knowledge throughout the project to internal resource(s).
- Adhere to and promote quality practices and behaviours.
- Experience delivering computerised systems validation (CSV) activities within a GxP regulated context is essential.
- Experience delivering cloud based software solutions and data migration between systems is essential.
- Previous experience in validation of ERP systems is essential.
- Previous experience with User Acceptance Testing and Functional Risk Assessments
- Previous experience of Oracle/Oracle Cloud is highly desirable
- Experience with one or more of the following ERP processes is highly desirable
- Warehouse Barcoding & material/inventory management
- Product quality release
- Equipment Maintenance
- Product manufacturing
- Experience within the pharmaceutical industry, generating and executing documentation to GxP standards is essential.
- In depth knowledge of relevant regulatory agency guidance in relation to Computer Systems Validation, including FDA, EMA, GAMP5, ICH and authorities in other major geographic areas, is essential.
- Previous experience of working as part of large multi-disciplinary project team is desirable.
- The ability to integrate with large teams, communicate with people from a wide variety of backgrounds and to develop relationships is essential
- Experience in the use of electronic document management systems (EDMS) is desirable, although specific training will be provided.
- Experience using a paperless validation system for the execution of validation tests is desirable, although specific training will be provided.
- Proven ability of accurate and timely completion of tasks.
- Excellent verbal, written and interpersonal communication in English.
- Proven ability to be able to manage changing situations with efficiency, calmness and purpose with the thought to all parts of the business.

About The Company