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 Lead to join the Operations group, reporting directly to the VP of Software Development. 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.

You will be a seasoned validation expert (GxP,GCP) who will be responsible for the creation and management of Validation Solutions providing a valuable service to both internal and external clients. Ensuring that the Risk Assessment Based Validation solutions are maintained in line with Product Releases.

 

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

  •         Responsible for the management and maintenance of the Validation solutions for all products for which there is a commitment to a Customer for a Validation project.
  •         Overall responsibility for issues relating to Validation.
  •         Provide assistance with Sales, Customer Support and other areas.
  •         Liaise and agree with project managers in the planning of Validation activities on Customer sites.
  •         Capable of performing the role of Validation Consultant
  •         Responsible for Quality and for maintaining the associated procedures relation to Validation Services
  •         Responsible for Staff Development & Resource allocation in conjunction with the VP of Software Development
  •         Ensure adherence to our documented Quality Management System in all tasks associated with this role
  •         Drive a profitable Validation service
  •         Ability to engage with the development Test Function to leverage test evidence for validation solutions.

 

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

  • Risk based assessment skills in validation strategies
  • Ability to identify non-conformances, and preparing for agency audits.
  • Experienced with managing and working with off shore teams and resources.
  • Proven management abilities.
  • Strong Commercial awareness.
  • Strong Knowledge of software testing.
  •       Training or experience in biotechnology, quality management, and process controls would be an advantage.      
  •        Understand 21 CFR Part 11 Compliance Gap Remediation for Computerized Systems.
  •        Ability to perform consultation on retrospective validations for required computerized systems
  •        Planning and performing the periodic review of computerized Systems Periodic Review as per the SOP
  •  Prepare and review Departmental SOPs and providing trainings to client and internal team.

  

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