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
Jack Caffrey
Life Science

01 507 9279
[email protected]
Connect with me on
Hot Science Jobs
Snr Associate QC
Dublin
Chemistry Technical Sales Representative
Cork
Clinical Trials Associate Fluent Italian
Cork
Senior Regulatory Affairs Specialist
Dublin
Equipment Project Engineer
Limerick
Staff Project Manager
Dublin West
Senior Project Engineer
Cork
Clinical Project Manager
Dublin
Business Development Director Europe Con
Dublin
Study Start Up Associate - Dutch
Cork
Process Engineer Scientist
Dublin
Director of Regulatory Affairs
Dublin
Clinical Project Manager Remote working
Republic of Ireland
Manufacturing Engineer
Galway
Technical Scientist
Cork
Quality Manager
Dublin
Senior Project Engineer
Cork
CMC-Development Regulatory Associate
Cork
Senior Validation Engineer
Limerick
Project Manager - Project Controls
Limerick
Clinical Trial Start Up Associate - Nati
Cork
Manufacturing deviations specialist
Dublin
Project Engineer
Limerick
Senior Validation Engineer
Limerick
Team Leader - Vendor Management
Waterford
CMC Regulatory Associate
Cork
Senior Tech Transfer Lead
Dublin
Polymer Scientist
Galway
Senior Mechanical Engineer
Dublin
Quality Engineer
Cork
Clinical Trials Project Manager
Cork
Senior Lab Analyst
Waterford
Publications Scientific Communications A
Cork
Device Provisioning Coordinator - Health
Dublin
Clinical Project Manager Part time Optio
Dublin
Quality Systems Specialist
Cork
Technical Sales Engineer
Galway
Jr Quality and Commissioning Technician
Kilkenny
Senior Manufacturing Engineer - Cell Sup
Limerick
Principal R&D Engineer
Dublin
Project Engineer
Limerick
Industrial engineer -Supply Chain
Dublin
CMC Regulatory Specialist
Cork
Global Demand Analyst
Limerick
Industrial Engineer
Dublin
Snr QA Associate
Dublin
QC Scientist
Limerick
Senior Manufacturing Engineer
Cork
Process Engineer
Limerick
Senior QC Specialist
Dublin
Technology Transfer Engineer
Cork
Materials Controller (Biopharma - Dublin
Dublin
Senior Quality Assurance Specialist
Dublin
eClinical Project Manager
Republic of Ireland
Project Lead - Packaging Virtual Team
Cork
Clinical Trials Start up Associate Fluen
Cork
Project Engineer
Kilkenny
Process Engineer
Dublin North
Equipment Engineer II
Galway
Project Engineer
Galway
Associate Clinical Project Manager
Dublin
Project Manager Manufacturing - Senior
Cork
Qualified Person
Waterford
Medical Director Clinical Development Ps
Dublin
Quality Engineer
Galway
Quality and Commissioning Technician
Kilkenny
Senior MES Engineer
Dublin
Manufacturing Project Engineer
Cork
Business Program Lead - Remote
Republic of Ireland
Graduate Quality and Commissioning Techn
Kilkenny
Operations Lead/ Engineer
Republic of Ireland
Senior Project Engineer
Cork
Recruitment Consultant
Dublin
Senior R&D Engineer
Limerick City
QP Manager
Dublin
Analytical Services Supervisor
Waterford
Internal Technical Sales Specialist (Mol
Dublin
Sr Electrical Engineer
Galway
Senior Associate QC
Dublin
Quality Engineer
Cork
Clinical Trials Start Up Associate Fluen
Cork
Validation Lead
Limerick
Business Excellence Specialist
Cork
Lab & Instrument Technician
Limerick City
Quality Engineer - Validation
Limerick
CMC Regulatory Specialist
Cork
Technical Scientist
Cork
Senior R&D Engineer-New Product Deve
Westmeath
Project Scheduler
Limerick
R&D Manager
Galway
C&Q Engineer
Dublin
Territory Manager Ireland (Life Sciences
Tipperary
Packaging Engineer
Galway
Senior PMO Project Manager
Dublin
Senior Business Development Manager (Nur
Republic of Ireland
Senior R&D Project Manager
Limerick City
QA Senior Associate
Dublin
Quality Defects and Recall Inspector
Dublin
Manufacturing Engineer
Cavan
Quality Engineer II
Wexford
Senior Materials Engineer
Cork
Quality Engineer
Limerick
Manufacturing Process Specialist
Cork
Internal Commercial Sales Support Repres
Dublin
Supply Chain Manager
Dublin
Clinical Research Associate (CRA)
Republic of Ireland
Project Scheduler
Limerick
Senior Clean Utilities / Process Enginee
Limerick
QC Microbiology (Senior)
Dublin
Regulatory Affairs Project Lead
Cork
Program Manager - EUMDR
Waterford
Manufacturing Project Engineer
Cavan
Project Manager
Limerick
Injection Moulding Engineer
Limerick
Planner
Limerick
Team Leader - Vendor Management
Waterford
Regulatory Affairs Specialist
Limerick
Senior Quality and Regulatory Manager
Galway
Senior Project Manager Engineering
Limerick
QC Analyst
Cork
Senior Regulatory Affairs
Galway
Operations Lead/ Project Engineer
Dublin
Facilities Maintenance Fitter
Dublin
Research Support Officer
Cork
Smart Asset Maintenance Specialist
Cork
QA Specialist - Supplier Quality
Cork
Procurement Operations Manager
Dublin
Associate Quality Engineer
Galway City
CQV Engineer (Remote)
Dublin
Principal Systems Engineer
Limerick
Senior Quality Assurance Specialist
Dublin
Technical Document Writer
Limerick
Clinical Trial Associate German Speaking
Cork
Graduate Engineer
Limerick
Snr Quality Engineer
Galway
Senior Planner
Limerick
Project Engineer
Limerick
Clinical Trials Manager
Dublin
R&D Manager
Limerick
Operations Lead/ Engineer
Republic of Ireland
MES/POMS specialist
Longford
R&D Engineer
Galway
eClinical Project Coordinator
Republic of Ireland
Surgical Territory Account Manager (Orth
Dublin
Study Start Up Associate
Cork
QA Manager
Dublin
QA Manager
Cavan
R&D Engineer
Limerick City
Head of R&D
Galway
Senior Electronic Engineer
Limerick
Clinical Trials Operations Manager
Cork
Quality Engineer
Galway
Principal Material Scientist
Dublin
Quality Operations Team Lead
Waterford
Senior Design Quality Engineer
Galway
Senior Moulding Engineer Lead
Limerick
Shift Production Manager
Waterford
Quality Engineer
Dublin
Publications Scientific Communications A
Cork
Manufacturing Engineer
Cork
Pharmacoepidemiology Analyst
Cork
Senior Manufacturing Engineer-Operations
Dublin
Project Engineer
Limerick
External Research Project Lead
Cork
Device Provisioning Coordinator Healthca
Dublin
Materials Coordinator
Waterford
Industrial Product Designer
Dublin
Clinical Trial Capabilities Assistant Fl
Cork
Senior Recruitment Consultant
Dublin
Director of Regulatory Affairs
Dublin
Snr Associate QC
Dublin
R&D Engineer
Galway
Supply Chain Manager
Dublin
Sales Manager (Clinical Diagnostics)
Dublin
Quality Systems Manager
Galway
Technical Writer
Limerick
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

QA Specialist


Reference:JSC0008589 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Analyst

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Cork. 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.

Duties

We have an exciting opportunity for a QA Specialist to join our expanding team in Cork to help support the Quality Operations unit.
The QA Specialist will be responsible for the following.
Managing compliance activities and QA operational activities related to operational project as required by Good Manufacturing Practice (GMP). These activities include, C&Q and Validation activities, Data Integrity and CSV support, change control, non-conformance investigations, compliance auditing, and other related quality system elements.
You will have fulfilled the educational requirements for this role and have experience in a similar role within a FDA/EMEA regulated environment.
What you’re great at:
• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Customer focus
• Innovative
• Excellent communication skills both written and verbal
• Attention to detail
• Good problem solving skills
• Results and performance driven
• Adaptable and flexible
• Integrity, trustworthiness and objectivity
• Knowledgeable of FDA/EMEA regulatory requirements
• Supports GMP activities from operational through to Laboratory support programs.
• Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
• Responsible for implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP.
• Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture.
• Participates as a key quality member in inspections and audits of JSCI by external parties/agencies.
• Key participant within the QA team in the execution of their duties.
• Executes the activities of the group within quality to create a synergistic approach to goals and tasks.
• Domestic and international travel may be required.
Be vital:


KEY SKILLS & EXPERIENCE

• To Bachelor’s Degree in a scientific/technical discipline required
• A minimum of 5 years’ experience in a quality or compliance role within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
• Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
• Focus on patients and customers at all times.
Desirable:
• Advanced degree (MS, MBA, PhD) preferred
• Experience in C&Q, and Process validation
• Experience in direct interactions with regulatory agencies during site inspections.