Validation Manager


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2021-12-08 14:15:381970-01-01Team Horizon
Job TypePermanent
AreaSligoSligoIreland
SectorQualityManagement
Start Date
AdvertiserDarcy Ainscough-Denton
Job Ref#2285
Job Views163
Description

We are currently recruiting a Validation Managerto be part of our client’s leadership team at their state-of-the-art Biologics manufacturing & fill finish facility in the North West of Ireland. In this role you will report directly to the Quality Director, and you will lead a high performing team that is responsible for the development and maintenance of the biologics validation program and ensure company and external regulatory, quality, and compliance requirements are met.
 
Why you should apply:

  • Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
  • The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
  • Excellent career progression opportunities.

 
What you will bedoing:

  • Maintaining system availability
  • Develop, coach and mentor your team to perform to their highest capabilities
  • Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
  • Generation/maintenance/execution of Project Validation Plans and schedules
  • Generation of validation protocols and final reports to cGMP standards.
  • QA support for validation investigations and implementation of corrective actions.
  • Creation/Review/Approval of various validation and qualification documents
  • Management of validation, exception event, and change control processes.
  • Documenting all activities in line with cGMP requirements.
  • Performing cross training within the team and training of new team members.
  • Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
  • Coordinating activities to maximize the effectiveness of all of the team members.
  • Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

 
 
What you need to apply:

  • A relevant degree in engineering or scientific discipline with 3 years plus validation/Quality experience in sterile/aseptic environment especially in the commissioning and qualification area 
  • 3 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry
  • Demonstrated leadership capabilities to build and coach a diverse team
  • Ability to partner and provide technical expertise to wider leadership team and cross functional teams
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