QA Validation Engineer

https://www.teamhorizon.ie/job-search/1434-qa-validation-engineer/engineering/sligo/job2024-10-16 17:00:012052-02-29Team Horizon
Job TypeContractor
AreaSligo, IrelandSligoIreland
SectorEngineeringQuality
Start Date
AdvertiserAshling Guthrie
Job Ref3419
Job Views253
Description

Team Horizon is seeking a QA Validation Engineer for an initial 12-month contract at their Sligo based facility. In this role you will coordinate the development and maintenance of the site validation program and ensure external regulatory, quality, and compliance requirements are met.


 


 


Why you should apply:



  • Opportunity to join a state of the art facility and add value to exciting projects

  • Competetive rates on offer


 


What you will be doing:



  • Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards.

  • Generation/maintenance/execution of the Site Validation Master Plan.

  • Generation/maintenance/execution of Project Validation Plans and schedules.

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

  • Generation of validation investigations and implementation of corrective actions.

  • Creation/Review/Approval of various quality documents and test data.

  • Management of validation, exception event, and change control processes.

  • Maintenance and tracking of validation equipment, if applicable.

  • Completing all required training before executing a task.

  • Documenting all activities in line with cGMP requirements.

  • Updating of validation procedures, job instructions and batch documentation to reflect current best practices.

  • 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.

  • Maintaining the overall cGMP compliance of the production areas.

  • Communicating with peers and management regarding activities in the area, including elevation of events or concerns.


 


What you need to apply:



  • Qualification and/or degree in engineering or scientific discipline. 

  • 3 years plus of knowledge of cGMP, validation and regulatory requirements relating to the biopharmaceutical industry.

  • Strong communication (written and oral), presentation and troubleshooting skills required

  • Effective interpersonal and organizational skills.

  • Ability to work well both independently and in a team environment.

  • Capable of prioritizing work and multitasking.


 


 

Apply Later
Sign in
Register
Apply
Later
Ashling Guthrie
Browse Ashling's jobs
Get in touch with Ashling
Similar Jobs
  • Reliability Engineer
    Ireland, Mayo
    Engineering

    Team Horizon is seeking a Reliability Engineer for a leading manufacturing company in Mayo.

    The reliability engineer will champion continuous improvement to reduce the levels of risk to the business for both equipment and utility related issues on site and ensure engineering compliance wi...

  • Automation Project Engineer
    Ireland, Mayo
    Engineering

    Automation Project Engineer

    Team Horizon is seeking a Automation Project Engineer for a global manufacturing company in Mayo. This role entails managing large, strategic and/or complex automation projects and automation process improvements activities across the site. Strategic planning f...

  • R&D Product Technical Manager
    Ireland, Galway
    Engineering

    R&D Product Technical Manager

    Team Horizon is seeking a R&D Product Technical Manager for a client in Galway. The product Technical Manager is accountable for the deliverables of R&D due to ensure the success of the project. As well as the detailed scheduling and budgeting of ...

Email Me Jobs Like This
Subscribed to similar jobs notifications
Name:*
E-mail:
Subject
Phone
Textarea:
We use cookies to provide you with the best possible browsing experience on our website. You can find out more below.
Cookies are small text files that can be used by websites to make a user's experience more efficient. The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission. This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages.
+Necessary
Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.
ResolutionUsed to ensure the correct version of the site is displayed to your device.
essential
SessionUsed to track your user session on our website.
essential
+Statistics
Statistic cookies help website owners to understand how visitors interact with websites by collecting and reporting information anonymously.
Google AnalyticsGoogle Analytics is an analytics tool to measure website, app, digital and offline data to gain user insights.
Yes
No

More Details