Validation Team Lead


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https://www.teamhorizon.ie/903-validation-team-lead/engineering/sligo/job2023-03-24 12:11:551970-01-01Team Horizon
Job TypePermanent
AreaSligo, IrelandSligoIreland
SectorEngineeringQuality
Start Date
AdvertiserAshling Guthrie
Job Ref2871
Job Views878
Description
Are you passionate about managing and leading people?

We have an exciting opportunity available for a Validation Team Lead for our clients pharmaceutical manufacturing facility in the Northwest.

 

Why you should apply:



  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


  • Join a company whose goal is to help patients live healthier lives and are proud to be a Great Place to Work.


 

 

What you will be doing:



  • You will lead, coach and mentor your Validations team to success


  • Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.


  • Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards.


  • Generation/maintenance of the Validation Master Plans.


  • Generation/maintenance of Project Validation Plans.


  • Generation of validation protocols and final reports to cGMP standard.


  • Review / approval of all protocols and final reports.


  • Management of validation change control process.


  • Adheres to and supports all EHS & E standards, procedures and policies


  • We believe in collaboration so in this role, you will partner with cross functional teams across the business


Any other duties as assigned

 

 

What you need to apply:



  • 3rd level qualification in engineering or scientific discipline


  • 3-5 years’ experience in a cGMP regulated environment, with validation activities demonstrated successfully.


  • Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures.


  • Demonstrated leadership capability - experience building a strong diverse team and inspiring them to succeed.


  • This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned, and resolved.


  • Good communication and motivation ability is required.


 

 
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