Validation Consultant Job Opening in Instem, CSV, life science domain, computer system validation,Gxp
The Company Instem provides advanced and best-in-class IT solutions to the global health and life sciences community which improves the productivity of their processes in the discovery and development of new drugs, therapies and products.
We are actively looking for a Validation Consultant to join the Operations group, reporting directly to the Validation Manager.
As a Validation Consultant you will be responsible for providing support for system validation activities to our customers both Internal and External. This will include technical advice. consultancy, audits, Requirements assessments, risk assessments and practical assistance with validation test execution. This support may be required for a wide variety of bespoke and proprietary systems as well as our products. You will be involved in a total solution provision for our internal and external clients.
You will be involved with these tasks on a daily basis:
= Provision of practical validation support to internal and external customers
= Validation Document authoring and reviewing
= Validation test script creation, review, and execution
= Facilitation of Risk Analysis and other Validation support activities
= Creation of “typical workflow” diagram or documentation to provide requirements analysis.
= Development and review of test scripts (UAT or client facing)
= Creation and Maintenance of validation document templates
= Specification, conduct and reporting of computer validation audits and requirements assessments
= Maintaining an awareness of issues and industry best practice in the field of GxP regulations as they affect computer systems
= Contribution to Business Process Improvement initiatives
Ensure adherence to our documented Quality Management System in all tasks associated with this role
To succeed in this role, you will require the following skills:
= Appropriate combination of experience of in Validation of computer and software systems within GxP environment, computer system validation.
= Knowledge of Industry Standards such as CDISC, SEND, CFR21pt11, GAMP5 would be an advantage.
= Proven written and verbal communication skills
= Good knowledge of Microsoft Office products
= Working knowledge of our products, including current development schedule
= Effective time management
= Knowledge of our Quality Management System and its application to tasks associated with this role
Salary & Benefits
= 21 days paid holiday plus one extra day after 10 years’ service
= Public holidays
= Private group medical insurance whch covers you, your spouse, your parents and two dependent children under the age of 18
= Private group personal accident insurance
= Company sick pay for up to 12 weeks in any 12-month rolling period
Apply today and learn more about how along with us, you can help our customers bring life enhancing products to market faster.
For the more than 400 clients around the world, we are supplying breakthrough technology and services that help them efficiently access, capture, manage and enrich a wide array of data while generating new insight to advance their mission.
Join a cause – advance your career.
Learn more at http://www.instem.com/about/what-we-do.php
In this policy, you will find information about our compliance with GDPR (data protection law.) You can find how to send us a request to let you access your data that we have collected, request us to delete your data, correct any inaccuracies or restrict our processing of your data.