Quality Assurance Specialist
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #1002115 |
| Job Views | 587 |
- Description
- Our client has an exciting new opportunity working with and maintaining a change control system at a biotech in Swords, Dublin. You will be also act as the site’s change control subject matter expert. Collaboration with cross functional depts on-site in addition to engagement with site groups will be a key part of the role.
Why you should apply:
You will join an innovative team, working among a diverse group of visionaries, thinkers and doers, working on developing pioneering solutions that lead to shared success.
They put their people first and live their diversity and inclusion values embracing all
perspectives.
You enjoy working in a culture of learning and collaboration and making a positive impact.
What you will be doing:
Managing the Global Change Management process at the site as well as driving best practices, and streamlining of the Trackwise process to ensure the relevant procedures and best practices are applied in the creation, approval and execution of Trackwise records.
Optimising the health & wellbeing of the system at the site to ensure timely actions are taken to meet compliance & production needs
Helping SMEs for the various change types (e.g., automation, equipment, process),
Contributing to regulatory and compliance inspections at the site with the support of the change type SMEs as needed
Guiding site users.
Approving and maintaining of user access and submission of User Access Request forms as well as, when necessary, review, approval and submission of Selection Value Requests & TR Reset Requests
Generation of metric data for Site Leadership review and awareness
Ensure the timely completion of annual user access verification
Cross train with some key QMS support activities including documentation management overview.
What you need to apply:
Bachelor's degree in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent
5-7 years’ + experience in in Quality Assurance/ Quality Systems
Outstanding knowledge of relevant Quality and Compliance Guidelines (Quality Management Systems, cGMP, Change Control) and respective regulations.
Ability to become an inspiring member of a high performing team.
Be passionate about building the future of the company
Aptitude to continuously learn, improve and develop
Great communication skills
A decisive decision maker and proven ability to deliver excellence
Confidence to direct off-site suppliers to the project, willingness to support the team and a laser light focus to deliver excellence
Strong relevant knowledge of cGMPs, regulations and current industry trends.
Skilled at new product introductions and/or process qualification/technology transfer
