Validation Manager

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
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The Role

We are actively looking for a driven Validation Manager to join the Operations group, reporting directly to the senior director of product services and support.

You will be responsible for managing the day-to-day activities of a validation team, covering the diverse range of modern and legacy products across the Instem portfolio and its supporting services for internal or external clients.

Knowledge of GxP is essential. As the Validation Manager will be responsible for the production of Validation Packages (Solutions) in accordance with the Validation strategy, providing a valuable service to both internal and external clients. They will ensure that the Validation solutions are maintained in line with Product 

 

You will be involved with these tasks on a daily basis:

  •       Responsible for insuring Validation Solutions adhere to the Validation Strategy.
  •       Provide assistance to Sales, Customer Support and other areas.
  •       Capable of performing the role of Validation Consultant
  •       Responsible for the Quality produced from the Validation Services team
  •       Responsible for Staff Development & Resource allocation in conjunction with the VP of Software Development
  •       Adhere to our documented Quality Management System in all tasks associated with this role
  •       Engage with the development Test Function to leverage test evidence for validation solutions.
  •       Liaise with the Validation Liaison Consultant for guidance on the Validation Strategy.
  •       Conducting and managing validation activities.
  •       Ability to identify non-conformances and preparing for agency audits.
  •       Ability to perform consultation on retrospective validations for required computerized systems
  •       Continuous improvement of the validation team output
  •       Adhere to Departmental PAS and providing training to client and internal team
 

To succeed in this role, you will require the following skills:

  •     Good project and people management skills
  •     Knowledge of Validation Toolsets: Visio, Word, Excel, ALM solutions
  •     Awareness of the quality requirements of Validation
  •     Knowledge of Quality Management Systems and their application to tasks associated with this role
  •     Demonstrable commercial awareness.
  •     Strong Knowledge of software testing.
  •     Awareness of the drug development process
  •     Knowledge and understanding of 21 CFR Part 11 and similar regulatory expectations

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 dependant 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