
QA Specialist
14 hours ago
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 R&D, 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.
Responsibilities:
- Deliver Quality Assurance support to the Packaging Department.
- Evaluate and approve GxP documentation.
- Conduct Batch Record Review and Batch Disposition processes.
- Update Quality Assurance Standard Operating Procedures (SOPs) as necessary.
- Scan and archive documents as needed.
- Inspect finished products.
- Perform investigations into deviations and conduct Root Cause Analysis.
- Generate reports for customer complaints.
- Conduct line clearance for packaging areas.
- Suggest process enhancements and recommend changes.
- Assist with internal and regulatory audits/inspections as required.
- Support the training and mentoring of new employees.
- Provide additional support and assistance on tasks and projects as directed by management.
- Collaborate with cross-functional teams.
- Achieve agreed-upon KPIs and metrics.
- Perform other duties as necessary.
Skills and Experience:
- A relevant third-level qualification in a QA discipline.
- A minimum of 2-3 years of relevant industrial experience in a QA role, preferably in the pharmaceutical sector.
- Experience with Batch Record Review in Pharma/Med Devices is essential.
- Demonstrable understanding of Document Control principles, Quality Systems, and GMP requirements.
- Comprehensive knowledge of document control processes and the relationship between document change processes and products.
- Familiarity with the current pharmaceutical industry and relevant regulations, including 21 CFR, GxP, and ICH guidelines.
- Proficiency with Electronic Document Management Systems (EDMS).
- Stay informed about compliance requirements in your work area.
- Exhibit strong problem-solving skills with attention to detail.
- Proficiency in Microsoft Office applications and experience with Oracle.
- Excellent written and verbal communication skills, coupled with strong interpersonal skills.
- A proactive attitude toward customer service and performance.
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
#J-18808-Ljbffr
-
Qa Validation Specialist
2 weeks ago
Cork, Cork, Ireland Qa Resources Full time(fusion_builder_container type="flex" hundred_percent="no" hundred_percent_height="no" min_height="" hundred_percent_height_scroll="no" align_content="stretch" flex_align_items="flex-start" flex_justify_content="flex-start" flex_column_spacing="" hundred_percent_height_center_content="yes" equal_height_columns="no" container_tag="div" menu_anchor=""
-
Qa Validation Specialist
22 hours ago
Cork, Cork, Ireland Qa Resources Full time(fusion_builder_container type="flex" hundred_percent="no" hundred_percent_height="no" min_height="" hundred_percent_height_scroll="no" align_content="stretch" flex_align_items="flex-start" flex_justify_content="flex-start" flex_column_spacing="" hundred_percent_height_center_content="yes" equal_height_columns="no" container_tag="div" menu_anchor=""
-
Qa Validation Specialist
4 weeks ago
Cork, Cork, Ireland Qa Resources Full time[fusion_builder_container type="flex" hundred_percent="no" hundred_percent_height="no" min_height="" hundred_percent_height_scroll="no" align_content="stretch" flex_align_items="flex-start" flex_justify_content="flex-start" flex_column_spacing="" hundred_percent_height_center_content="yes" equal_height_columns="no" container_tag="div" menu_anchor=""
-
Qa Specialist
5 hours ago
Cork, Cork, Ireland Uniting Holding Full timeCatalyx is seeking a QA Specialist to join our team and work on our customer site in Cork.The QA Specialist is responsible for the creation, revision, and delivery of GMP documentation to our FDA-regulated customers.Who We Are:Catalyx specializes in the science of operational processes.With a footprint across North America and Europe, the company carefully...
-
Qa Specialist
1 day ago
Cork, Cork, Ireland Catalyx Full timeCatalyx is seeking a QA Specialist to join our team and work on our customer site in Cork.The QA Specialist is responsible for the creation, revision, and delivery of GMP documentation to our FDA-regulated customers.Who We Are: Catalyx specializes in the science of operational processes.With a footprint across North America and Europe, the company carefully...
-
Gaming Qa Specialist
22 hours ago
Cork, Cork, Ireland Void Interactive Full timeWe're VOID Interactive, the kickass team behind the best-selling FPS game,Ready or Not.We'remade up of some seriously talented individuals who love games and creating awesome content together.We'reseekinga dedicated and enthusiastic Gaming QA Specialist to join us remotely and help us elevateReady or Notto new heights.Our goal is strong: toestablishReady or...
-
QA Specialist II
2 weeks ago
Cork, Cork, Ireland Gilead Full timeJob DescriptionAt Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health...
-
QA Specialist II
2 weeks ago
Cork, Cork, Ireland Gilead Sciences Full timeSocial network you want to login/join with:At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the...
-
QA Validation Experts Wanted
1 day ago
Cork, Cork, Ireland beBeeValidation Full time €80,000 - €95,000Contract QA Validation Specialists NeededJoin us for an exciting opportunity to work on a contract basis as a QA Validation Specialist. This project is based in Cork and offers the chance to collaborate with a dynamic team.Job DescriptionAs a QA Validation Specialist, you will be responsible for reviewing IQ/OQ/PQ protocols and reports for software,...
-
Qa/Qc Engineer
2 weeks ago
Cork, Cork, Ireland Specialist Technical Services (Sts Group) Full timeElectrical QA/QC Technician or EngineerJoin STS Group as our next QAQC Technician or Engineer in CorkWe are looking for an experienced QAQC Technician / Engineer to join our Life Sciences (pharma) projects in Cork.STS Group is a proud member of the Dussmann Group, we have a healthy pipeline of work both locally in Ireland and overseas in Mainland Europe.This...