Find quality systems specialist Jobs in cork, c

IT Validation Specialist
Catalyx —Cork, County Cork
- Computer Science
- ERP systems
- Analysis skills
Quick apply
PI Engineer
Cognizant —Cork, County Cork
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The Irish Examiner & The Echo —Cork, County Cork
- Full-time
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Sales Order Management Administrator
PPL Biomechanics —Cork, County Cork
- From €32,000 a year
- Full-time
- ERP systems
- In-person
- Communication skills
Quick apply
1d
Global Operational Technology Engineer
PepsiCo —Cork, County Cork
- Computer Science
- SQL
- Bachelor's degree
International Education Specialist – Sales Consultant | Mongolia and Japan Market
SEDA College —Cork, County Cork
- €20,000–€30,000 a year
- Part-time
- Sales
- English
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- Flexitime
Quick apply
Team Leader Oncology Senior / Specialist Registrar Oncology Cover P301800
Bon Secours Health System Ireland —Cork, County Cork
- Full-time
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Manufacturing Engineer ( 12 Month FTC)
AbbVie —Cork, County Cork
- Full-time
- Communication skills
Senior Ecologist – Freshwater / Aquatic Specialist
Tetra Tech —Cork, County Cork
- Master's degree
Field Operations Engineer
Statkraft —Cork, County Cork
- Full-time
- Hybrid work
- Engineering
- Maintenance
- English
Quick apply
Customer Operations Executive - Cork
Ohme —Cork, County Cork
- €25,000–€35,000 a year
- Full-time
- Hybrid work
- Spanish
- Salesforce
- English
- Work from home
- Sick pay
Quick apply
8d
Junior Electrical Engineer / CAD Technician
Automated Systems & Controls —Cork, County Cork
- Full-time
- AutoCAD
- CAD
- Electrical Engineering
Quick apply
12d
Site Agent / Project Manager - Cork City & County
McGinty & O'Shea —Cork, County Cork
- Civil Engineering
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CSV Engineer
Cognizant —Cork, County Cork
- Full-time
- Hybrid work
- Computer Science
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- Bachelor's degree
6d
EMEA Payroll Specialist
FMC Agro Ireland Limited —Cork, County Cork
- Full-time
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- Human resources
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Senior Fire Investigator - Ireland
Jensen Hughes —Cork, County Cork
- Remote
- Research
- Analysis skills
- Communication skills
Quick apply
General Operative/Driver
Fireseal Contractors Ltd —Cork, County Cork
- €18–€22 an hour
- Full-time
- Driving
Quick apply
Healthcare Assistant - Relief
Bon Secours Health System Ireland —Cork, County Cork
- €16.81 an hour
- Weekend availability
- English
- Leaving certificate
- No degree
Industrial Pipe Fitter
Johnson Controls —Cork, County Cork
- Overtime
- Assembly
- No degree
- Computer skills
- Annual leave
- Sick pay

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IT Validation Specialist

Catalyx -
Cork, County Cork

Quick apply

Job details

Qualifications

Computer Science
ERP systems
Laboratory information management systems
Analysis skills
Bachelor's degree
IT
Communication skills
SDLC
Information Technology

Full job description

Catalyx is seeking an IT Validation Specialist join our team and work on our customer site in Cork.

Who We Are:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services RD, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai.

The Role:

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.

We are seeking an experienced IT Validation Specialist to join our team working within the pharmaceutical sector. This role is critical in ensuring that all IT systems and software comply with regulatory standards, operational requirements, and industry best practices. The ideal candidate will have a strong background in IT Infrastructure, computer system validation (CSV) and regulatory compliance with prior experience in a pharmaceutical or highly regulated environment.

Responsibilities:

Manage the qualification of IT systems, including hardware, software, and infrastructure within a GMP lab setting.
Validate software applications used in manufacturing, quality control, and other pharmaceutical processes.
Collaborate with software vendors to ensure system validation documentation is complete and accurate.
Manage the lifecycle of validated software, including upgrades and decommissioning.
Perform periodic reviews of validated systems to ensure continued compliance.
Develop and maintain traceability matrices to ensure alignment with user requirements.
Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Author, review and approve validation documentation, including validation plans, reports, and risk assessments.
Ensure all validation activities comply with regulatory standards such as GxP, FDA 21 CFR Part 11, and EMA
guidelines
Prepare validation summaries, deviation reports, and corrective/preventive action (CAPA) plans.

Skills and Experience:

Bachelor’s degree in Computer Science, Information Technology, or a related field.
3+ years of experience in IT validation, preferably in a pharmaceutical or regulated environment.
In-depth knowledge of GxP regulations, FDA 21 CFR Part 11, and other relevant standards.
Experience with validation of ERP, LIMS, MES, and other pharma-specific IT systems.
Strong understanding of software development lifecycle (SDLC) and validation best practices.
Familiarity with IT infrastructure, database management, and networking in a validated environment.
Excellent problem-solving, analytical, and organizational skills.
Strong written and verbal communication skills, with the ability to present validation results to diverse audiences.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.

Quick apply

Refine Your Search

quality systems specialist jobs in cork, c

IT Validation Specialist

PI Engineer

Fire Investigator - Ireland

Digital Production Journalist (Audience)

Sales Order Management Administrator

Global Operational Technology Engineer

International Education Specialist – Sales Consultant | Mongolia and Japan Market

Team Leader Oncology Senior / Specialist Registrar Oncology Cover P301800

Manufacturing Engineer ( 12 Month FTC)

Senior Ecologist – Freshwater / Aquatic Specialist

Field Operations Engineer

Customer Operations Executive - Cork

Junior Electrical Engineer / CAD Technician

Site Agent / Project Manager - Cork City & County

CSV Engineer

EMEA Payroll Specialist

Senior Fire Investigator - Ireland

General Operative/Driver

Healthcare Assistant - Relief

Industrial Pipe Fitter

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