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
Product Development Engineer
Galway
Injection Molding Engineer
North Leinster
Aseptic Process Owner Lead
Dublin
Aseptic Process Lead
Carlow
CSV Engineer - IT Labs
Limerick
Director of Quality Engineering
Limerick
QA Specialist (hybrid)
Cork
R&D Manager
Galway
Validation Engineer
Limerick
R&D Engineer
Clare
Senior Equipment Design Engineer
Dublin
Senior Technical Scientist - Technical T
Cork
Product Lead
Dublin
Cleaning Validation Specialist
Carlow
Senior Reg Affairs Specialist - Post Mar
Galway
Scientific Technical Specialist
Dublin
Senior Design Engineer
Dublin
Cleaning Validation Engineer
Denmark
Qualified Person
Limerick
QC Laboratory Technician (shift)
Carlow
R&D Engineer
Dublin
Shift Technician (Injection Moulding)
Kildare
Senior Associate Quality Control
Dublin
Project Engineer
Republic of Ireland
Senior Quality Engineer
Galway
R&D Engineer
Galway
R&D Lifecycle Manager
Connaught
Manufacturing Engineer
Cork
Bioprocess Material Associate - Shift
Dublin
Regional Program Coordinator - Global Le
Dublin
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
Lead Maintenance Reliability Engineer
Westmeath
Biostatistician
Dublin City Centre
R&D Manager
Galway
Senior Design Quality Engineer
Dublin
Clean Utilities Engineer
Carlow
Senior Project Engineer - Utilities
Dublin
R&D Engineer
Galway
Head of R&D
Galway
Senior R&D Engineer
Dublin
Senior Operations Engineer
Galway
Business Manager (Pharma Chemicals)
Westmeath
Manufacturing Technician
Clare
Operational Excellence Specialist
Meath
Principal R&D Engineer
Galway
Project Manager
Limerick
Senior Regulatory Affairs
Galway
Production Operator
Carlow
R&D Engineer
Clare
Chemical Engineer
Tipperary
Validation & Verification Engineer
Dublin
Product Development Engineer II
Athlone
Senior R&D Manager - Lifecycle Manag
Galway
C&Q Lead
Tipperary
Microbiology Manager
Dublin
Process Engineer
Cork
Maintenance Reliability Engineer
Tipperary
Qualified Person
Limerick
Senior Recruitment Consultant
Republic of Ireland
Project Enginer
Dublin South
Senior Recruitment Consultant
Republic of Ireland
Senior Electronic Engineer
Dublin
Quality Control Technician
Carlow
Project Manager - Capital Projects
Cork
Clinical Research Physician (CRP) and He
Cork
Project Engineer
Limerick
Senior R&D Engineer
Galway
Maintenance Reliability Engineer
Cork
Manufacturing Technician
Clare
Facilities Engineer
Carlow
R&D Director
Galway
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
Lead Maintenance Reliability Engineer
Westmeath
Electrical Engineer
Limerick
Senior R&D Engineer-New Product Deve
Westmeath
Quality Specialist
Tipperary
Process Engineer - Technical Specialist
Cork
R&D Manager
Connaught
Quality Manager
Dublin
Senior Associate Quality Control
Dublin South
Quality Engineer
Athlone
Senior Quality Engineer
Leitrim
Recruitment Consultant
Republic of Ireland
Quality Engineer
Athlone
EHS Systems Specialist
Dublin
Senior Regulatory Affairs Specialist
Athlone
Validation Engineer
Cork
Senior Electrical Engineer
Galway
Lead Maintenance Reliability Engineer
Westmeath
Senior Recruitment Consultant
Dublin
Injection Moulding Engineer
Athlone
R&D Director
Galway
Senior Human Factors Engineer
Dublin
Senior E&I Maintenance Technician
Carlow
(Senior) Manufacturing Engineers - Globa
Limerick
R&D Project Manager
Galway
CQV Lead
Tipperary
Principal Scientist Global Regulatory Af
Limerick
R&D Director
Galway
Validation Engineer
Carlow
Process Engineer (NPI)
Carlow
Senior Research and Development Engineer
Galway
EHS Specialist
Carlow
Clinical Project Statistician
Cork
Quality Technician
Dublin
Scientific Assistant – Quality and Pro
France
R&D Manager
Galway
Specialist Operations Engineer
Tipperary
Medical Science Liaison (MSL)
Dublin
QC Microbiology Technician
Carlow
Downstream Manufacturing Engineer
Dublin
Senior Electronic Engineer
Dublin
Sourcing Specialist
Tipperary
Senior Associate Quality Control NPI
Dublin
Manufacturing Technician
Clare
QC Laboratory Technician Shift (Incoming
Carlow
R&D Engineer
Dublin
Sr. Associate - Quality for Computer Sys
Cork
Biostatistician
Dublin City Centre
Senior Maintenance Technician
Carlow
Maintenance CMMS Engineer
Tipperary
R&D Manager
Connaught
Technology Transfer Specialist (Technica
Cork
R&D Engineer
Galway
Mechanical Technician - 2 Cycle
Carlow
Process Development Engineer
Galway
R&D Manager
Connaught
Compliance Specialist
Carlow
Senior R&D Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
Notified Body Product Assessor -Active D
Canada
Medical Device Director
Republic of Ireland
Senior Validation Engineer
Cork
Senior Design Assurance Engineer
Galway
E&I Turnover Engineer
Carlow
Senior Associate Quality Control NPI
Dublin
Senior Polymer Development Engineer
Galway
Senior Process Engineer
Cork
Principal R&D Engineer
Dublin
Senior R&D Engineer
Dublin
QC Laboratory Technician
Carlow
Procurement Senior Specialist
Meath
Senior Design Engineer
Dublin
Documentation Specialist
Cork
Senior R&D Engineer
Clare
Quality Validation Engineer
Limerick
Senior Quality Engineer-Remote
Republic of Ireland
Microbiologist
Louth
Project Manager - Capital Projects
Meath
R&D Director
Galway
Senior Quality Engineer
Galway
Principal Process Equipment Engineer
Dublin South
Technical Marketing Manager
Wexford
Senior Design Assurance Engineer
Galway
Sr. Associate - Quality for Computer Sys
Limerick
Mechanical Design Engineer
Germany
EHS Systems Specialist
Carlow
R&D Engineer
Galway
Quality Engineer
Athlone
Engineering Business Manager
Dublin
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Manager
Athlone
Warehouse Operations Specialist
Louth
Project Manager - Suite Lead
Tipperary
Senior Recruitment Consultant
Cork
Cleaning Validation Specialist
Cork
Quality Engineer
Galway
R&D Manager
Galway
CMC Regulatory Principal Scientist
Cork
Change Control Coordinator
Carlow
Senior Equipment Design Engineer
Dublin
Principal/Senior R&D Engineer Cathet
Galway
Account Manager UK and Ireland
Republic of Ireland
Senior Operations Engineer
Galway
Staff R&D Engineer- Customer Focus
Dublin
Manufacturing Project Engineer
Mayo
QA Manager
Canada
Biomedical Engineer
Dublin
QC Bioassay Analyst (shift)
Carlow
Injection Molding Engineer
North Leinster
Senior Validation Engineer
Dublin
Production Operator
Carlow
Maintenance CMMS Engineer
Tipperary
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Validation Specialist - 50/50 remote
Carlow
Project Manager - R&D
Galway
Electrical and Instrumentation Turnover
Carlow
Senior Project Engineer
Cavan
Cell Culture Analyst
Carlow
Electronic Design Engineer
Galway
Associate Quality Specialist
Tipperary
Technical Specialist - Analytical &
Cork
Quality Management System Specialist
Cork
Project Engineer
Tipperary
Principal Heart Valves Engineer
Galway
Senior Quality Engineer
Leitrim
Senior Manufacturing Engineer - (NC,CAPA
Limerick
Process Engineer
Limerick
Senior R&D Manager - Lifecycle Manag
Galway
Quality Assurance Engineer
Longford
Software Design Assurance Engineer
Dublin
Procurement Senior Specialist
Meath
Associate Director Clinical Regulatory S
Cork
Quality Technician
Dublin
Principal Software Engineer
Athlone
Product Development Engineer
Galway
Engineering Shift Technician
Dublin
Senior R&D Engineer
Galway
Senior Mechanical Engineer
Dublin
Product Development Engineer II
Athlone
Senior Design Engineer
Dublin
Packaging Engineer
Dublin
Quality Control Technician
Carlow
Manufacturing Engineer
Galway
Senior Associate Scientist (Shift)
Dublin
Senior R&D Engineer
Dublin
Process Validation Engineer
Cork
Quality Manager - NPI
Dublin
QA Manager
Canada
Project Engineer
Roscommon
QA Engineer
Leitrim
QA Operations Specialist
Greece
Senior Quality Control Associate
Dublin South
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

Quality Specialist dRP


Reference:SCA013970 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Specialist, Quality Assurance Officer, Quality Specialist, Quality Systems Specialist

Quality Specialist Deputy Responsible Person (dRP)
Our client, a leading and expanding pharmaceutical (Distribution) organisation, are currently recruiting for a Quality Specialist Deputy Responsible Person (dRP) to join their team on a permanent basis.
As Quality Specialist Deputy Responsible Person (dRP) you will be responsible for the quality oversight of the distribution of products within the Supply Chain. You will ensure product shipments are managed in compliance with GDP requirements and in line with the organisations procedures.


Responsibilities

  • Assist in the development, implementation and maintenance of the Quality Management System
  • Ensure Good Distribution Practice (GDP 2013/C 343/01) and current Health Products Regulatory Authority (HPRA) guidelines (IA-G0046) are adhered to covering all GDP activities performed
  • Assist in ensuring the Quality processes are compliant and well understood across the business through continuous training, retraining and informative communications.
  • Ensure all staff are initially trained upon commencement of employment and that a continuous training program is in place for all current and new employees
  • Ensure that only the relevant authorised product classes are procured from approved suppliers and supplied to approved customers and are covered under the Company’s Wholesale Distribution Authorisation
  • Assist in the approval of outsourced service providers and assist in route qualifications of transport providers as planned and required
  • Review, Draft and Approve documentation including change controls, deviations, validation documentation, SOP’s etc
  • Complete relevant initial and ongoing Bona Fide checks on suppliers and customers as assigned
  • Ensure and maintain a companywide risk management culture
  • Review and update Quality Technical Agreements as required and ensure Technical Agreements are in place with all suppliers, customers, and outsourced service providers
  • Returns – Identify returns within the supply chain and manage accordingly, reporting same to the RP as they arise, ensuring all returns are held in the secure returns area awaiting their fate, ensuring returns are not made available for sale unless approved by the RP
  • Assess temperature-controlled shipments and provide corresponding quality decision on product
  • Monitor and assess all temperature-controlled activities within the supply chain including the monitoring of the organisations warehouse temperature
  • Escalate any known or suspected Adverse Reactions (ADRs) and or serious Product Quality defects to the RP for onward reporting to the relevant Competent Authority and the relevant Product Authorisation holder as applicable
  • Recalls – ensure coordination and actioning of any recall activity for medicinal products are conducted immediately upon notification within a controlled and compliant manner
  • Act as dRP on the organisations Wholesale Authorisation and fulfil all the responsibilities and duties on behalf of the RP in their absence and ensure that a handover of information is completed prior to the absence and the returning of the named RP to work
  • Conduct any duties required as delegated to the dRP from the RP, keeping all records of these duties and activities appropriately recorded
  • Ensure that continuity of supply is maintained but ensure that no commercial decision made has any impact on the quality/patient/product safety
  • Escalate any known or suspected Falsified Medicines to relevant Competent Authorities and relevant product authorization holder as soon as possible
  • Ensure that a key focus is maintained at all times on the accuracy of the quality records within the organisations Quality Management System and related GDP system
  • Carry out duties / projects as assigned by the Quality Manager
Responsibilities
  • 3+ years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment
  • Thorough knowledge of temperature-controlled activities
  • Thorough knowledge of cGMPs/GDPs and global regulatory requirements
  • Sound awareness and understanding of pharmaceutical WDA business models, especially with regards to quality and regulatory requirements.
  • Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment
  • Good verbal and written communication skills with well-structured communication and ability to present to various audience levels
For more information please contact Sinéad Cullen on +353879500821 or [email protected]