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
Hot Science Jobs
QA Specialist (QC)
Cork
Senior QC Associate - BioAnalytical Scie
Dublin
VP Technical Operations
Galway
Procurement Manager
Dublin
Production Manager
Dublin City Centre
Manufacturing Process Specialist
Cork
Hospital Specialist (Clinical)
Dublin
Medical Information Agent Fluent Spanish
Cork
Validation Engineer
Limerick
Project/Process Engineer
Australia
MES Operations Analyst
Limerick
Plant QA Senior Associate (Inspection &a
Dublin
Manufacturing Human Performance Manager
Limerick
Process Scientist Manufacturing Support
Limerick
Senior QC & NPI Project Manager
Dublin
Senior R&D Engineer
Dublin
Manufacturing Specialist
Dublin
Administration Support
Dublin North
Associate Sourcing Director
Limerick
Technical Operations Engineer
Cork
API Purchaser
Dublin
Regulatory Affairs Manager
Galway
VP Strategic Marketing
Galway
Senior Electrical Engineer
Limerick
Program Manager
Westmeath
Project Manager
Dublin
Validation Engineer
Australia
O2C Analyst
Cork
CSV Engineer
Cork
QA Specialist - External Manufacturing
Limerick
Technical Operations Cleaning Validation
Cork
Senior EHS Associate
Dublin
QA Specialist
Cork
Project Manager R&D PMO
Mayo
Quality Manager
Dublin South
General Manager-Operations
Australia
Overall Equipment Efficiency Engineer
Limerick
Quality Engineer
Dublin
Scientist - Cellular Bioassay
Westmeath
In Vitro Diagnostics Operations Manager
Dublin
QA Specialist
Cork
Manufacturing Engineer
Galway City
Quality Control Analyst (Biopharma)
Carlow
Project Manager
Cork
Process Engineer (Oral Solid Dose)
Dublin
Quality Engineer - Validation
Mayo
Recruitment Resourcer
Dublin
Lab Support Manager
Offaly
Quality Engineer
Limerick
Senior Quality Engineer - Med Device
Limerick
Biostatistician
Dublin City Centre
German Speaking Medical Information Agen
Cork
Engineering Technician
Dublin
Research & Development Engineer
Galway
Manufacturing Specialist
Dublin
Head of Third-Party Manufacturing Tech S
Dublin
Technical Specialist
Athlone
Systems Project Engineer (Medical Device
Limerick
Validation Engineer
Galway
Senior Electronic Design Engineer
Galway
Quality Engineer
Dublin
Materials Project Leader - Additive Manu
Cork
Accounts Receivable Associate
Cork
Senior Scientist - Chemistry
Limerick
Senior QC Associate - HPLC
Dublin
Risk Manager
Dublin
Senior Technical Writer
Limerick
Project Equipment Engineer
Limerick
Global Supply Chain Analyst
Limerick
NPI Project Manager
Dublin
Project Engineer
Dublin
IPC Analyst
Cork
External Manufacturing Manager
Limerick
Senior Project Planner
Limerick
Senior Quality Team Lead
Dublin
Strategic Sourcing Specialist - Indirect
Cork
QA Specialist
Cork
CTO
Galway
Process Sciences Manager
Limerick
Senior R&D Engineer
Dublin
QC Bioassay Analyst
Cork
Senior QC Associate
Dublin
Electronic Engineer (Medical Devices R&a
Limerick
Senior Director Operational Strategy
Dublin
Engineering Technician
Dublin
Process Engineer
Limerick
Project/Process Engineer
Australia
Category Manager - MRO & Engineering
Kildare
Production Support Specialist
Dublin
Process Engineer
Cork
Senior Supply Chain Planner
Dublin
Senior R&D Project Manager
Mayo
EHS&S Senior Specialist
Cork
Project Engineer
Cork
Maintenance Manager
Dublin
Senior Social Work Practitioner
Republic of Ireland
Quality Compliance Specialist
Australia
Regulatory Affairs Specialist
Galway
CSV Engineer
Dublin
Process Engineer
Dublin
Process Development Engineer
Dublin
Senior Regulatory Affairs Specialist
Galway
Research & Innovation Projects Engin
Cork
QC Process Microbiologist
Cork
NPI Project Engineer
Cork
Project Engineer (Medical Devices)
Limerick
Senior Analytical Scientist
Limerick
Research and Development Programme Manag
Waterford
EHS Specialist
Cork
R&D Engineer
Dublin
R&D Engineer - Mechatronics
Galway
Quality Assurance and Regulatory Affairs
Dublin North
Senior Quality Engineer
Cork
Scientific Communications Manager
Cork
Sr Associate - Quality Control
Dublin
Master Data Management
Kildare
R&D Engineer
Dublin
Global Head of Manufacturing
Dublin
NPI Project Engineer
Cork
Quality Assurance Specialist
Cork
QC Trainer
Cork
Quality Engineer
Dublin South
QA Specialist
Dublin
Senior Empower Lab Analyst
Cork
QC Microbiology Manager
Dublin
Consultant
Cork
QC Lab Analyst
Sligo
Equipment Engineer
Dublin
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
Connect with me on
Close

Sign up for Qualified Person jobs email alerts

Email *


Frequency of Alert *

Daily Weekly Monthly
Search Results for Qualified Person
Job Title. Location Salary Actions

VP Quality Assurance & Regulatory Affairs

VP of Quality Assurance & Regulatory Affairs Life Science Recruitment are currently sourcing an VP of Quality Assurance & Regulatory Affairs for a MedT

Location: Galway,
VP Quality Assurance & Regulatory Affairs 		Galway Not Disclosed

Quality Assurance and Regulatory Affairs Manager

Quality Assurance and Regulatory Affairs Manager Our client, one of the largest biomedical innovator based in Dublin is looking to recruit QA/RA Manager wh

Location: Dublin North,
Quality Assurance and Regulatory Affairs Manager 		Dublin North Not Disclosed
Other Pharmaceutical Jobs
Job Title Location Salary Actions
R&D Formulation Scientist Galway Not Disclosed
Technical Sales Specialist (Service Department) Dublin Not Disclosed
Principal QA Validation Specialist Limerick Not Disclosed
QA Validation Manager Limerick Not Disclosed
Subscribe RSS feed for this search

Qualified Person Career Profile

Qualified Person (QP)

The QP is the person responsible for the final release of a batch of pharmaceutical product, finished products that are ready for consumption only. To do this, they must review all of the batch files, which encompass information from many of the other departments. A QP is named on a manufacturing licence and must be qualified according to Directive 2003/94/EC. This is granted by taking a specific 2 year course, or by having a Pharmacy degree plus the required experience. Salaries in this area range from €60,000 to €90,000 for an experienced QP. Many QPs also offer their services on contract, services numerous facilities simultaneously. A desireable and lucrative job for many working in the Pharmaceutical industry.

Minimum of five years experience in a Quality role.

Key Responsibilities of the QP


  • Before certifying a batch prior to release the Qualified Person doing so should always ensure that the following requirements have been met:
  • Each batch of finished product must be certified by a Qualified person within the EC/EEA before being released for sale or supply in the EC/EEA or for export.
  • The principles and guidelines of GMP as stated in Directive 2003/94/EC for medicinal products and IMP for human use, as interpreted in the EC Guide to GMP have been followed. Ensure all requirements under references have been met prior to release of a batch.
  • The principal manufacturing and testing processes have been validated.
  • All the necessary Quality Control checks and tests have been performed, and account taken of the manufacturing and packaging conditions including a review of batch records.
  • All necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes
  • All necessary manufacturing, packaging and quality control documentation has been completed and endorsed by suitably authorised staff.
  • To ensure that the legal requirements regarding imported products have been fully met.
  • The general conditions as laid down on the Manufacturer's License orManufacturing Authorisation (IMB) are followed.
  • The QP should maintain their knowledge and experience up-to-date in the light of technical and scientific progress and changes in quality management relevant to the products which they are required to certify.
  • The QP must carry out audits of GMP facilities involved in the manufacturing of medicinal products used in the clinical study.
  • The QP must maintain a register of all released batches.
  • The QP must promote GMP through training and guidance internally.