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.
Google Chrome |
Internet Explorer |
Mozilla Firefox |
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
Product Development Engineer
Dublin
Dublin
Clean Utilities Engineer
Carlow
Carlow
R&D Director
Galway
Galway
Product Development Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Manufacturing Engineer
Limerick
Limerick
Senior HVAC Engineer
Dublin
Dublin
Quality Engineer
Wexford
Wexford
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Validation Engineer
Carlow
Carlow
Senior Mechanical Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Quality Engineer
Galway
Galway
Quality Manager - NPI
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Principal R&D Engineer
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
Embedded Software Engineer
Dublin
Dublin
Senior Operations Manager
Tipperary
Tipperary
R&D Engineer
Dublin
Dublin
Director of Quality Engineering
Limerick
Limerick
Senior R&D Engineer
Dublin
Dublin
Senior Quality Engineer
Limerick
Limerick
Maintenance CMMS Engineer
Tipperary
Tipperary
R&D Manager
Galway
Galway
Senior Engineering Manager
Limerick
Limerick
Graduate R&D Engineer
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior QC 24/7 Shift
Dublin
Dublin
Aseptic Process Lead
Carlow
Carlow
Senior Quality Engineer
Dublin
Dublin
Project Process Engineer
Carlow
Carlow
Product Development Engineer
Galway
Galway
Manufacturing Engineer
Galway
Galway
Graduate Laboratory Technician
Republic of Ireland
Republic of Ireland
QC Bioassay Analyst (shift)
Carlow
Carlow
Manager/ Senior Manager Drug Product Man
Republic of Ireland
Republic of Ireland
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
E&I Turnover Engineer
Carlow
Carlow
Operations Specialist
Louth
Louth
Principal R&D Engineer
Galway
Galway
QC Bioanalytical Analyst
Dublin
Dublin
Clinical Affairs Manager
Galway
Galway
Trainer
Dublin
Dublin
Sourcing Specialist
Tipperary
Tipperary
Aseptic Process Owner Lead
Dublin
Dublin
Process Development Engineer
Galway
Galway
Maintenance CMMS Engineer
Tipperary
Tipperary
Project Manager
Louth
Louth
Facilities Engineer
Carlow
Carlow
Senior R&D Manager/Director
Dublin
Dublin
Design Assurance Engineer
Galway
Galway
Strategic Automation Lead
Waterford
Waterford
Associate Quality Specialist
Tipperary
Tipperary
Quality Manager
Dublin
Dublin
Project Engineer
Clare
Clare
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Quality Engineer
Galway
Galway
Senior Regulatory Affairs
Galway
Galway
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior R&D Project Manager
Galway
Galway
R&D Director
Galway
Galway
Quality Technician
Dublin
Dublin
C&Q Lead
Tipperary
Tipperary
R&D Director
Galway
Galway
Medical Device Director
Republic of Ireland
Republic of Ireland
Senior Operations Engineer
Galway
Galway
Manufacturing Engineer
Wexford
Wexford
QC Chemistry Analyst
Carlow
Carlow
Process Support Specialist
Carlow
Carlow
Process Engineer (Shift)
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Senior Validation Engineer
Limerick
Limerick
Quality Engineer
Athlone
Athlone
Clean Utilities Engineer
Carlow
Carlow
Engineering Manager
Clare
Clare
Project Engineer
Limerick
Limerick
Senior EHS Specialist
Louth
Louth
Engineering Shift Technician
Dublin
Dublin
Project Manager
Limerick
Limerick
Biomedical Engineer
Dublin
Dublin
Electrical Engineer
Cork
Cork
Production Operator
Carlow
Carlow
Senior Quality Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Associate Quality Specialist
Tipperary
Tipperary
Senior Validation Engineer
Dublin
Dublin
Principal R&D Engineer
Galway
Galway
Distribution Centre Manager
Dublin
Dublin
Product Development Engineer
Galway
Galway
Quality Systems Specialist
Galway
Galway
Biomedical Engineer
Dublin
Dublin
Chemical Engineer
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Project Engineer
Tipperary
Tipperary
Senior Electronic Engineer
Dublin
Dublin
Laboratory & Quality Manager
Dublin
Dublin
R&D Program Manager
Dublin
Dublin
Maintenance Engineer
Cork
Cork
R&D Senior Program Manager
Galway
Galway
Quality Technician
Dublin
Dublin
Quality Technician
Carlow
Carlow
QA Associate Specialist
Carlow
Carlow
Engineering Business Manager
Dublin
Dublin
Microbiology Manager
Dublin
Dublin
Quality Engineer
Athlone
Athlone
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Manufacturing Technician
Clare
Clare
Principal R&D Engineer
Dublin
Dublin
Electronic Design Engineer
Galway
Galway
Project Engineer
Republic of Ireland
Republic of Ireland
Quality Specialist (hybrid)
Tipperary
Tipperary
Maintenance Reliability Engineer
Tipperary
Tipperary
CQV Lead
Tipperary
Tipperary
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Quality Validation Engineer
Limerick
Limerick
Quality Systems Manager
Dublin
Dublin
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
EHS Systems Specialist
Carlow
Carlow
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Validation Engineer
Cork
Cork
Suite Team Delivery Lead
Tipperary
Tipperary
Senior Quality Engineer
Dublin
Dublin
R&D Director
Galway
Galway
Quality Specialist
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Senior Validation Engineer
Dublin
Dublin
QC Chemistry Analyst (Shift)
Carlow
Carlow
Process Support Specialist
Carlow
Carlow
Senior R&D Engineer
Clare
Clare
Recruitment Consultant
Wexford
Wexford
QC Analyst
Meath
Meath
EHS Systems Specialist
Dublin
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Specialist Operations Engineer
Tipperary
Tipperary
Facilities Engineer
Carlow
Carlow
Quality Systems Specialist
Dublin
Dublin
Pharmaceutical Operator
Louth
Louth
QC Laboratory Technician
Carlow
Carlow
Process Engineer
Cork
Cork
Senior Associate Quality Control
Dublin South
Dublin South
Senior R&D Engineer
Dublin
Dublin
Process Support Specialist
Carlow
Carlow
Aseptic Process Lead
Carlow
Carlow
Senior Electrical Engineer
Galway
Galway
Senior Associate Quality Operations
Limerick
Limerick
Senior Validation Engineer
Limerick
Limerick
Senior Electronics Engineer
Dublin
Dublin
Process Engineer
Limerick
Limerick
Electrical Engineer
Limerick
Limerick
Principal Process Equipment Engineer
Dublin South
Dublin South
Head of R&D
Galway
Galway
Quality Technician
Dublin
Dublin
Packaging Engineer
Dublin
Dublin
Qualified Person
Limerick
Limerick
Change Control Coordinator
Carlow
Carlow
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Quality Systems Enginer
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
Validation Engineer
Limerick
Limerick
E&I Turnover Engineer
Carlow
Carlow
Engineering Projects Lead
Carlow
Carlow
Maintenance Engineer
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Manufacturing Shift Lead
Donegal
Donegal
Production Operator
Carlow
Carlow
Senior Quality Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Quality Manager - NPI
Dublin
Dublin
Senior Process Enginer
Dublin South
Dublin South
Project Manager - Suite Lead
Tipperary
Tipperary
Program Manager
Cork
Cork
R&D Manager
Galway
Galway
EHS Project Lead
Cavan
Cavan
R&D Manager
Galway
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Associate Global Trade Ops
Dublin
Dublin
Senior Technical Writer
Dublin
Dublin
Maintenance Planner
Carlow
Carlow
Quality Manager
Dublin
Dublin
Automation Engineer
Cavan
Cavan
Process Engineer
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Digital Lab Records Specialist
Tipperary
Tipperary
Senior R&D Engineer
Clare
Clare
Quality Manager
Clare
Clare
Product Development Engineer
Galway
Galway
Senior Project Manager - Process Develop
Dublin South
Dublin South
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Apply for this job
Details
Qualified Person
Reference: | SCAXSG-348663 | Location: |
Limerick Limerick City |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: | 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
- 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
Supply Chain Microbiology Academic Scientific Medical Affairs Chemistry Biopharmaceutical Connected Health Cork PhD Engineering Pharma Sales Limerick Cork City Clinical Research Mayo IT Quality Control Life Science Academic Sales and Marketing Allied Healthcare Project Manager Biotechnology Sales and Marketing Packaging Engineer Manufacturing Executive Supply Chain Diagnostics Medical Device Dublin Laboratory Scientist Product Development Engineer Scientist Validation Engineer Pharmaceutical Quality Assurance Quality Engineering
Group sites:
Medical Affairs Jobs | Clinical Research Jobs | Biotechnology Jobs | Biopharmaceutical Jobs | Scientific Jobs | Science Jobs | Engineering Jobs | Quality Assurance Jobs | Supply Chain Jobs | Chemistry Jobs | Contract Jobs | Pharmaceutical Jobs | Medical Device Jobs | Connected Health Jobs
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS