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 [email protected]
Details

Qualified Person (Hybrid)


Reference:RK23521 Location: Meath
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Qualified Person

Qualified Person (Hybrid)
RK23521
Contract – 6 months
Meath



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Meath. 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:

  • Bring energy, knowledge, innovation, and leadership to carry out the following:
  • Perform Qualified Person (QP) duties in certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
  • Assure batch manufacturing and testing has been performed in accordance with cGMP and the relevant marketing authorization (MA) or clinical trial authorization, product specification file, legal obligations and/or technical agreement. Manage and/or escalate any potential CGMP and/or other concerns in a timely manner.
  • Provide oversight of deviations (including approval of significant deviations) and laboratory investigations related to drug substance manufacture, testing and those that may present potential effect on product and /or material.
  • Confirm change requests with product impact which require expanded review (e.g., regulatory, stability, testing impact) have been appropriately reviewed, approved and technically closed.


Educational and Experience
  • BSc. degree (or higher) in Biotechnology, Chemistry, Biology or in a relevant discipline.
  • EU QP Qualification
  • 5years experience of certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
  • Expert level of knowledge of relevant GMPs, regulations and current industry trends.



If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.