Computer Systems Validation Specialist

3 weeks ago

Northwich, United Kingdom Dechra Pharmaceuticals PLC Full time

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 colleague 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
**The Challenge**
- Responsible for delivery the Computer Systems Validation aspects of the project in accordance with project objectives and timescales.
- Oversight of all Computer Systems Validation activities for the project (including vendor(s) and implementation partners).
- Working collaboratively across the business to ensure that the validation is delivered on time and compliantly.
- Engaging with vendors in relation to qualification/validation activities.
- Demonstrate role model leadership, train and coach to support and improve individual performance and business results.
- Transfer of knowledge throughout the project to internal resource(s).
- Drive, champion and promote quality practices and behaviours.

**About You**
- Experience delivering cloud based software solutions and data migration between platforms is essential.
- Previous experience in validation of ERP systems is essential.
- Significant experience of Oracle/Oracle Cloud is desirable
- Experience in the pharmaceutical industry, generating and executing documentation to GxP standards is essential.
- Strong leadership skills with the ability to challenge, influence, and build consensus.
- 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 systems (EDMS), electronic quality management systems (EQMS) and electronic validation execution systems 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.

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