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
Rachel Kent
Life Science

+353 87 427 8808
[email protected]
Connect with me on
Hot Science Jobs
Quality Operations Manager
Dublin
Design Assurance Program Manager
Galway
R&D Director
Galway
Product Development Engineer
Dublin
Manufacturing Engineer
Galway
Program Manager
Dublin
R&D Engineer
Galway
Project Engineer - Senior
Cavan
Senior Regulatory Specialist
Cork
Embedded Software Engineer
Dublin
Application Software Engineer
Galway
Electronic Engineer
Dublin
Injection Moulding Engineer
Leitrim
Senior Recruitment Consultant
Republic of Ireland
Senior Engineering Manager
Limerick
R&D Engineer
Galway
Senior R&D Engineer
Galway
Quality Manager - Medical Devices
Limerick City
R&D Engineer
Galway
Product Development Manager
Galway
R&D Lifecycle Manager
Connaught
Senior R&D Engineer
Galway
R&D Engineer
Dublin
Product Development Engineer
Galway
Senior R&D Engineer
Clare
Senior Mechanical Engineer
Dublin
Design Assurance Program Manager
Galway
Senior R&D Engineer-New Product Deve
Westmeath
R&D Engineer
Galway
Software Design Assurance Engineer
Dublin
Injection Molding Engineer
North Leinster
R&D Engineer
Galway
Project Manager
Louth
Product Development Engineer II
Athlone
Operational Excellence Specialist
Cork
Design Quality Engineer
Galway
Documentation Specialist
Louth
Quality Engineer
Athlone
Principal R&D Engineer
Galway
Manufacturing Technician
Clare
Principal R&D Engineer
Galway
Senior Quality Assurance Specialist (hyb
Dublin
Documentation Specialist - Upstream Oper
Dublin
Regulatory Affairs Specialist
Cork
Principal R&D Engineer
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
MS&T Scientist - AKTA systems
Meath
Project Manager (hybrid)
Dublin
R&D Engineer
Galway
Technical Marketing Manager
Wexford
R&D Engineer
Clare
Learning Systems Lead
Limerick
Senior Operations Engineer
Galway
R&D Engineer
Dublin
Design Assurance Engineer
Clare
Electronic Engineer
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Senior Quality Engineer
Leitrim
Senior Recruitment Consultant
Republic of Ireland
Sourcing Specialist
Tipperary
Senior Equipment Engineer
Dublin
Senior Validation Engineer
Louth
R&D Manager
Athlone
Site Microbiologist
Republic of Ireland
R&D Manager
Connaught
Manufacturing Engineer
Cork
R&D Manager
Galway
Product Development Manager
Galway
Product Development Engineer
Dublin
Clinical Research Manager
Cork
QA Manager
Canada
Maintenance Reliability Engineer
Cork
Product Development Engineer
Dublin
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
Design Assurance Engineer
Galway
Product Development Engineer
Galway
Project Manager
Kildare
Quality Manager - NPI
Dublin
Advanced Technologies R&D Manager
Clare
Mechanical Technician - 2 Cycle
Carlow
Senior R&D Engineer - Sustaining
Galway
Process Chemist
Limerick
Clinical Research Associate
Cork
Design Assurance Engineer
Clare
Senior Quality Engineer
Dublin
Principal R&D Engineer
Dublin
Customer Services Manager (Pharmaceutica
Dublin
Mechanical Engineer
Dublin
Warehouse Operator
Meath
Quality Engineer
Galway
Principal R&D Engineer
Galway
Quality Manager
Dublin
Senior Quality Engineer
Leitrim
Manufacturing Project Engineer
Mayo
R&D Manager
Galway
R&D Director
Galway
Senior Equipment Design Engineer
Dublin
QC Bioanalytical Sciences - Senior Assoc
Dublin
Principal Engineer
Dublin
R&D Director
Galway
Senior Design Assurance Engineer
Galway
Senior Quality Assurance Specialist (Shi
Dublin
Principal R&D Engineer
Galway
Calibration Technician
Republic of Ireland
Principal Instrumentation & Calibrat
Limerick
R&D Manager
Galway
Principal Quality Engineer
Galway
MS&T Bioprocess Engineer
Meath
Senior R&D Engineer
Galway
R&D Engineer
Galway
Senior Validation Engineer
Dublin
Senior R&D Engineer
Galway
Quality Control Analyst (shift)
Carlow
Project Engineer
Roscommon
Project Manager - R&D
Galway
Principal R&D Engineer
Dublin
Manufacturing Technician
Clare
Project Manager - R&D
Galway
Senior Quality Engineer
Dublin
Engineering Support Specialist
Louth
Warehouse Operator
Meath
Senior Regulatory Affairs Specialist
Athlone
Senior Process Engineer
Dublin
Operations Engineer
Galway
Manufacturing Engineer
Cork
CTO
Dublin
Senior Quality Systems Engineer
Galway
Product Specialist (Peripheral Endovascu
Dublin
Health & Safety Specialist
Dublin
Clinical Research Associate
Cork
R&D Manager
Athlone
Quality Engineer
Galway
Injection Moulding Engineer
Athlone
Senior Equipment Design Engineer
Dublin
Senior Electronic Engineer - Regulated M
Galway
R&D Engineer
Galway
Senior Operations Engineer
Galway
Senior R&D Manager
Athlone
Senior R&D Engineer
Galway
Senior R&D Engineer - Sustaining
Galway
Senior Design Assurance Engineer
Athlone
Quality Assurance Team Lead
Cork
Injection Moulding Engineer
Athlone
R&D Manager
Connaught
Senior Electronic Engineer
Dublin
Sr R&D Manager
Galway
Senior R&D Engineer
Galway
R&D Manager
Galway
Advanced Technologies Manager
Galway
Mechanical Technician
Carlow
Senior Regulatory Affairs Specialist
Athlone
Process Development Engineer
Galway
Senior Process Development Engineer
Galway
Senior Associate Quality Control
Dublin
Principal R&D Engineer
Galway
QA Engineer
Leitrim
Senior Quality Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Maintenance & Reliability Technician
Limerick
Quality Specialist
Tipperary
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Maintenance Technician
Kilkenny
R&D Manager
Dublin
Technical Life Cycle & Engineering M
Galway
Senior R&D Engineer
Galway
Associate Analytical Scientist
Meath
Injection Molding Engineer
North Leinster
Principal Device Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Electronic Engineer
Dublin
Reg Affairs Specialist
Connaught
R&D Manager
Connaught
Senior R&D Engineer
Dublin
Senior Associate Quality Control (Shift)
Dublin
Senior Technical Transfer Specialist
Cork
Project Engineer
Clare
Senior Regulatory Specialist
Cork
Principal R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Reliability Engineering Consultant - Rem
Republic of Ireland
Senior Quality Control Associate
Dublin South
Technology Transfer Specialist
Meath
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
R&D Project Manager
Galway
Senior Design Engineer
Dublin
R&D Technician II
Galway
Advanced Technologies R&D Manager
Clare
Cleaning Validation Specialist
Cork
CTO
Galway
Senior QA CSQ/CQV Specialist
Republic of Ireland
Product Development Engineer
Dublin
R&D Manager
Connaught
Manufacturing Engineer
Wexford
Quality Assurance Specialist (hybrid)
Dublin
Manufacturing Technician
Galway
Electronic Engineering
Dublin
Quality Assurance Specialist (Logistics)
Dublin
Project Engineer
Limerick
Quality Engineer
Galway
Senior Electronic Engineer
Dublin
R&D Engineer
Galway
Project Engineer
Louth
Senior Regulatroy Affairs Specialsit
Galway
Senior Quality Engineer
Dublin
Senior Project Engineer
Cavan
Injection Molding Engineer
North Leinster
Quality Engineer
Galway
Lead Maintenance Technician
Kilkenny
Manufacturing Technician
Clare
Sr Electrical Engineer
Galway
Value Stream Team Leader / Production Su
Wexford
Senior R&D Manager - Lifecycle Manag
Galway
Materials Controller (Biopharma - Limeri
Limerick
Production Operator
Carlow
Manufacturing Project Engineer
Sligo
Regulatory Affairs Associate
Cork
Process Engineer
Galway
Sr Electrical Engineer
Galway
Sr R&D Manager
Galway
Senior Regulatory Affairs
Galway
Responsible Person (RP)
Republic of Ireland
Quality Manager
Dublin
Electrical Technician
Limerick
R&D Engineer
Galway
Regulatory Specialist
Galway
Senior Quality Systems Engineer
Galway
R&D Manager
Galway
Strategic Automation Lead
Waterford
Senior Regulatory Affairs Specialist
Athlone
Project Manager
Kildare
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

Senior QA CSQ/CQV Specialist


Reference:RK24125 Location: Republic of Ireland
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

Senior QA CSQ/CQV Specialist
RK24125
Contract 11 months
Louth



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Louth. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



This role is responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP and company SOPs. It includes validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, controlled temperature units (CTUs) and shipping



Key Responsibilities:

  • Ensure the quality oversight of the qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
  • Ensure that all validation documentation and associated data, including but not limited to; plans, URSs, quality risk assessments, protocols, and reports, are reviewed and approved by QA for conformance to SOPs, specifications and other applicable acceptance criteria.
  • Ensure that all events/deviations, investigations, and change evaluations that occur during qualification/validation activities have appropriate QA oversight, QA review and approval and adhere to SOPs and cGMP requirements.
  • Review SOPs relating to qualification/validation activities.
  • Provision of support in Regulatory inspections and Client audits.
  • Provision of QA Validations expertise to maintain validation status of the facility.
  • Maintain an understanding of cGMP regulations and guidance in relation to all aspects of validation and/or qualification of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
  • Coordinate all QA Validations activities to ensure schedule adherence and on time delivery of project deliverables.
  • Manage and develop the QA Validations team including, but not limited to, activities such as performance management, recruitment, and training.
  • Other quality activities as needed and assigned.


Education and Experience:
  • B.Sc or B.Eng in a Scientific or Engineering related discipline (e.g. biochemistry, chemistry, engineering).
  • 6+ years experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/ medical device manufacturing in a FDA/ EU regulated environment.
  • Deep knowledge of GxP regulations applicable to biologics manufacturing (e.g. EU-GMP, FDA, ISO) and the industry standards applicable to validation, including but not limited to; GAMP, ISPE, ISO, ASME and BPE.
  • Knowledge of trouble shooting and problem-solving skills. Knowledge of formal root cause analysis methods and tools such as Ishikawa diagrams, FMEA etc.

If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.