I'm looking for...
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
Contact Info
R&D Engineer
Dublin
Quality Manager
Dublin South
CSV Engineer
Dublin
QA Specialist
Dublin
Process Engineer
Limerick
Quality Engineer
Dublin South
API Purchaser
Dublin
Quality Engineer
Limerick
Administration Support
Dublin North
QC Trainer
Cork
Senior Social Work Practitioner
Republic of Ireland
Biostatistician
Dublin City Centre
Risk Manager
Dublin
Consultant
Cork
Program Manager
Westmeath
CTO
Galway
R&D Engineer
Dublin
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

QA Specialist - External Manufacturing


Reference:PORA005750 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Specialist, EHS Specialist

A QA Specialist/ Senior Specialist - External Manufacturing is required to join a leading biopharmaceutical organisation in Limerick. The focus of the role is to perform activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.

Responsibilities

  • Represent Quality Assurance both internally and Externally with Partners and Contract Manufacturers in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
  • Train and/or mentor junior employees, including providing insights and education on processes and procedures;
  • Provides consultation or advice in alignment with QA policies; and develop an understanding of external partner and manufacturers site procedures.
  • Perform activities associated with reading product records for disposition (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc.). Activities may be on site at a partner or contract manufacturer or at a desk
  • Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials.

The Person

  • Requires BS/BA in scientific discipline or related field
  • A minimum 2 years’ experience in a quality assurance role.
  • Experience of aseptic filling is essential
  • Good organizational skills and attention to detail
  • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally. and cross-organizationally.
  • Ability to handle multiple assignments and changing priorities.
  • Ability to work a varied schedule including off shift and weekends.
  • Ability to travel up to 25% of time





If you would like further Information you can contact the recruiter directly:



Paula O'Reilly | Tel: +353 (0) 1 507 9265