Forgot your Password?
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to applications@lifescience.ie
Details

Senior Quality Specialist - Risk Management


Reference:RK3939 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Specialist

Senior Quality Specialist - Risk Management
RK3939
Contract - 12 months
Cork



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Duties:

  • Execution of the Quality Risk Management (QRM) & Site Quality Risk Register (SQRR) processes ensuring effective governance, communication and management systems are in place and maintained.
  • Execution of the Quality Internal & External Audit/Inspections preparation and management processes for the Site (including follow up on audit action completion, associated CAPA’s, and NC Quality approval).
  • Participate in Site risk assessments.
  • Execute site and quality driven improvement projects as per the site Risk Register e.g. but not limited to,
  • Supplier Qualifications.
  • Reclassification of plant areas.
  • Site Data Integrity Program
  • Manages projects effectively to meet strict timelines and achieve established milestones with regular updates to Quality and Site Leadership Teams.
  • Quality Review and Approval of SOPs, Work Instructions and forms from other departments and periodic reviews.
  • Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a Quality perspective.
  • Quality review and approval of quality non-conformance (NC) records. Quality point of contact for attendance at Root Cause Analysis meetings.
  • Initiation and ownership of Quality non-conformance records.
  • Quality assessor, reviewer and approval of quality non-conformance (NC) records.

Experience and Education:
  • Third level Degree in a science or pharmaceutical discipline.
  • 3 to 5 years’ experience in a quality or compliance role within the biological and/or pharmaceutical industry.
  • Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
  • Experience with risk management projects, data integrity and driving improvements is a must


If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.