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
Job Tools
Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
Connect with me on
Hot Science Jobs
Senior Regulatory Affairs Specialist
Westmeath
Product Development Engineer
Dublin
Process Simulation Technical Engineer
Carlow
Mechanical Design Engineer
Germany
QC Micro Analyst (Shift)
Cork
Suite Team Delivery Lead
Tipperary
EHS Systems Specialist
Dublin
Chemical Engineer
Tipperary
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer
Leitrim
Senior Quality Engineer
Leitrim
R&D Manager
Connaught
Product Development Engineer II
Athlone
Sr. Associate - Quality for Computer Sys
Cork
Maintenance Reliability Engineer
Cork
R&D Engineer
Clare
Senior E&I Maintenance Technician
Carlow
Process Engineer (Shift)
Carlow
Senior Validation Engineer
Cork
CQV Lead
Tipperary
Senior R&D Engineer
Dublin
Microbiology Manager
Dublin
Senior Maintenance Technician
Carlow
R&D Technical Life Cycle & Engin
Galway
Senior Electronic Design Engineer
Dublin
EHS Specialist
Carlow
Senior Project Manager - Electrical
Dublin
Technical Life Cycle & Engineering M
Galway
Maintenance Engineer
Carlow
Validation Engineer
Cork
Senior Operations Engineer
Galway
Biostatistician
Dublin City Centre
Senior Manufacturing Engineer
Cork
R&D Engineer
Dublin
Manufacturing Project Engineer
Sligo
Quality Manager
Dublin
Manufacturing Technician
Clare
Senior Project Equipment Engineer
Dublin
Scientific Technical Specialist
Dublin
Production Operator
Carlow
Principal Process Equipment Engineer
Dublin South
Regional Procurement Senior Specialist (
Dublin
Senior Electrical Engineer
Galway
Quality Specialist - Remediation
Louth
Product Development Engineer II
Athlone
Project Engineer - Senior
Cavan
Cleaning Validation Specialist
Cork
QA Manager
Canada
R&D Manager
Galway
Sales/Customer Service Administrator
Clonmel
Manufacturing Technician
Clare
Senior R&D Manager - Lifecycle Manag
Galway
Facilities Engineer
Carlow
QC Laboratory Technician (shift)
Carlow
Principal Preclinical Scientist
Galway
Injection Moulding Engineer
Athlone
Account Manager UK and Ireland
Republic of Ireland
Quality Technician
Dublin
Senior Project Engineer
Cork
Business Systems Director
Louth
Manufacturing Technician
Clare
Reliability Engineering Specialist
Louth
Senior Associate Quality Control
Dublin South
Project Manager - Capital Projects
Meath
Senior Regulatory Affairs Specialist
Athlone
Quality Management System Specialist
Cork
Project/Process Engineer - Purification
Cork
R&D Engineer
Dublin
Project Engineer
Clare
Associate QA Specialist (Shift)
Carlow
Packaging Engineer
Dublin
Senior R&D Manager
Athlone
E&I Turnover Engineer
Carlow
Senior Equipment Design Engineer
Dublin
Senior Validation Engineer
Dublin
Project Manager - R&D
Galway
Upstream Manufacturing Process Specialis
Cork
Injection Moulding Engineer
Athlone
Biostatistician
Dublin City Centre
Regional Program Coordinator - Global Le
Dublin
Senior Design Assurance Engineer
Galway
Senior Project Engineer - Utilities
Dublin
Manufacturing Technician
Clare
Associate Director Clinical Regulatory S
Cork
Technical Transfer Specialist
Cork
Senior Research and Development Engineer
Galway
Senior Product Development Engineer
Galway
R&D Engineer
Galway
Senior R&D Engineer
Dublin
Senior Regulatory Affairs Specialist
Clare
Senior Recruitment Consultant
Republic of Ireland
Senior Project Manager - Process Develop
Cork
Senior R&D Engineer
Clare
Project Manager - R&D
Galway
R&D Manager
Connaught
R&D Director
Galway
Senior Equipment Design Engineer
Dublin
Senior Engineering Manager
Limerick
R&D Manager
Galway
Senior Operations Engineer
Galway
Embedded Software Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
Process Engineer - Technical Specialist
Cork
Project Manager - R&D
Galway
Quality and Regulatroy Manager
Galway
Senior Director Global Regulatory Lead E
Cork
Commissioning and Qualification Engineer
Dublin
Principal Process Development Engineer
Galway
R&D Engineer
Galway
Quality Engineer
Galway
R&D Manager
Galway
Product Lead
Dublin
(Senior) Manufacturing Engineers - Globa
Limerick
Senior Design Quality Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
Pharmacovigilance Manager (Remote)
Republic of Ireland
Principal/Senior R&D Engineer Cathet
Galway
R&D Director
Galway
Project Manager - Capital Projects
Cork
Qualified Person
Limerick
Warehouse Operations Specialist
Louth
Procurement Senior Specialist
Meath
R&D Manager
Connaught
Senior R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Senior Quality Engineer
Galway
Program Manager
Cork
R&D Director
Galway
Project Manager
Limerick
Senior Regulatory Affairs Specialist
Athlone
Aseptic Process Owner Lead
Dublin
Process Engineer
Galway
Injection Molding Engineer
North Leinster
Sourcing Specialist
Tipperary
R&D Engineer
Clare
Aseptic Process Lead
Carlow
Senior Quality Assurance Manager (REMOTE
Dublin
QA Operations Specialist
Greece
Senior Recruitment Consultant
Dublin
CQV Engineer (CIP Start Up)
Denmark
Quality Control Analyst
Greece
Senior Manufacturing Engineer - (NC,CAPA
Limerick
R&D Engineer
Galway
Manager R&D
Connaught
Maintenance Engineer
Cork
Senior Quality Engineer
Galway
Recruitment Consultant
Republic of Ireland
Facilities Engineer
Carlow
Principal R&D Engineer
Dublin
Senior Quality Engineer
Limerick
R&D Director
Galway
R&D Engineer
Galway
Senior Associate Quality Control NPI
Dublin
Manufacturing Technician
Clare
Lead Maintenance Reliability Engineer
Westmeath
Senior QC Associate
Dublin
Senior Equipment Design Engineer
Dublin
Project Enginer
Dublin South
Senior Operations Engineer
Galway
CMC Regulatory Senior Scientist
Cork
Quality Systems Specialist
Galway
Validation Engineer
Athlone
Process Engineer
Limerick
Principal R&D Engineer
Galway
Injection Molding Engineer
North Leinster
Senior Recruitment Consultant
Republic of Ireland
R&D Engineer
Galway
Medical Device Director
Republic of Ireland
Project Engineer
Limerick
Quality Engineer
Athlone
Senior Process Engineer
Cork
Qualified Person
Limerick
Senior Recruitment Consultant
Dublin
Quality Control Specialist (hybrid)
Carlow
R&D Lifecycle Manager
Connaught
Process Support Specialist
Carlow
Project Engineer
Roscommon
Commissioning, Qualification and Valid
Carlow
QA Manager
Canada
Quality Assurance Engineer
Longford
Principal Scientist Global Regulatory Af
Limerick
Change Control Coordinator
Carlow
R&D Program Manager
Dublin
Project Engineer
Republic of Ireland
Senior Electronic Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
QA Engineer
Leitrim
Senior R&D Project Manager
Galway
Head of R&D
Galway
Engineering Projects Lead
Carlow
Senior R&D Engineer
Dublin
Senior Validation Engineer
Dublin
Engineering Shift Technician
Dublin
Senior Electronic Engineer
Dublin
Senior R&D Manager/Director
Dublin
Senior Process Engineer
Cork
Manufacturing Engineer
Limerick
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Human Factors Engineer
Dublin
QA Specialist (hybrid)
Cork
Principal Software Engineer
Athlone
Clinical Project Statistician
Cork
Technical Transfer Specialist - Remote
Republic of Ireland
Quality Technician
Dublin
Clean Utilities Engineer
Carlow
Project Engineer
Tipperary
Senior R&D Engineer
Clare
C&Q Lead
Tipperary
CEP Revisions Team leader B5
France
Associate Global Trade Ops
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Maintenance CMMS Engineer
Tipperary
R&D Manager
Connaught
Senior Mechanical Engineer
Dublin
Senior Electronic Engineer
Dublin
Production Operator
Carlow
Senior Equipment Design Engineer
Dublin
Injection Molding Engineer
North Leinster
Quality Engineer
Athlone
Senior Equipment Design Engineer
Dublin
Senior Technical Scientist - Technical T
Cork
QC Chemistry Analyst (Shift)
Carlow
Senior Process Development Engineer
Galway
R&D Manager
Galway
Quality Specialist
Tipperary
Senior QC 24/7 Shift
Dublin
Senior R&D Engineer
Galway
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


Reference:SCAXSG-348663 Location: Limerick
Limerick City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person

Qualified Person
Our client, a global biotech,are seeking a highly motivated and detail-oriented Qualified Person to join the quality assurance team as the Lead QP onsite. The successful candidate will have previously been a named QP on a Irish licence previously.

Responsibilities

  • Ensure manufactured biotech drug substance (DS) batches are certified in accordance with all required regulations and in compliance with IND/CTAs/ manufacturing authorisation/ marketing authorisation
  • Ensure that biotech drug product batches are tested in compliance with manufacturing & marketing authorisations (BLA/MAAs/ROW CTDs)
  • Is responsible for the final decision associated with batch certification
  • Ensures that the principles and guidelines of GMP as stated in 2003/94EC, 2001/83EC, 536/2014 (repealing 2001/20/EC), associated EU GMP annexes, (e.g., Annex 13, Annex 16) and current product specification file (PSF) are met
  • Provide Quality leadership, direction, training and governance for the specific area of responsibility
  • Carry out day to day activities in compliance with site safety policy and procedure
  • Promote and encourage safe practices and promptly report any safety concerns
  • Continue to maintain knowledge and experience in line with technical and scientific progress for product(s) of responsibility in alignment with Annex 16 requirements.
  • Communication and education of personnel in GMP requirements and regulations.
  • Responsible for approving appropriate quality-related documents. An approval signature confirms that the company, GMP and relevant regulatory requirements have been met
  • Review and approve change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches
  • Review and approve GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data and periodic review reports (PRR) and annual product reviews (APR) product quality evaluations
  • Responsible for issuance of QP declarations where required
  • Understand the conditions and requirements when a renewed authorisation is necessary and ensure they are complied with
  • Evaluation and contribution of regulatory information to regulatory documents including review/approval of dossier sections as part of the product submission processes
Requirements
  • BSc, MSc, or PhD in Biology, Chemistry, Pharmacy, or related discipline
  • Must be approved by member state as a licensed QP in order to be named on the company licence as a QP
  • Minimum of 7 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment
  • Must have been on an Irish license previously as QP
For more information contact Sinéad Cullen on +3538795009821 or [email protected]