QA Specialist

2 weeks ago

Cork, Cork, Ireland Catalyx Full time
Overview

Catalyx 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.

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. The team benefits from a Total Rewards package including great personal benefits and professional growth opportunities. Catalyx is an Equal Opportunity Employer and we are committed to a diverse and inclusive workplace. 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 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

    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 Specialist

    2 weeks ago

    Cork, Cork, Ireland Westbourne IT Global Services Full time

    Position Overview:We are seeking a QA Specialist for a contract role within the Quality Assurance (QA) Department, specifically in the Quality Monitoring team. The successful candidate will support key quality activities including Annual Product Quality Reviews, Customer Complaint Investigations, Counterfeit Sample Assessments, QA Documentation Review &...

  • Qa Specialist

    2 weeks ago

    Cork, Cork, Ireland Uniting Holding Full time

    Catalyx 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 Compliance Specialist

    6 days ago

    Cork, Cork, Ireland beBeevalidation Full time €75,000 - €100,000

    Job Overview:">CQRA Resources is seeking contract QA Validation Specialists for a dynamic project based in Cork.">The ideal candidate will be responsible for reviewing IQ/OQ/PQ protocols and reports, developing validation protocols and reports to ensure compliance with regulatory requirements, and managing the site Validation Master Plan.">In addition, they...

  • QA Specialist

    2 weeks ago

    Cork, Cork, Ireland Uniting Holding Full time

    Catalyx 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...

  • Senior QA Specialist

    2 weeks ago

    Cork, Cork, Ireland Tandem Project Management Ltd. Full time

    OverviewA Senior QA Specialist is required for a pharmaceutical company in South Tipperary. The successful candidate will ensure that all operations align with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA. Onsite attendance is required during the training period. After training, the position offers one day of remote...

  • Gaming Qa Specialist

    2 weeks ago

    Cork, Cork, Ireland Void Interactive Full time

    We'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...

  • Senior Localization QA Specialist

    1 week ago

    Cork, Cork, Ireland beBeeLocalization Full time €42,000

    Localization QA Expert WantedWe are looking for highly skilled Localization QA Specialists to work on a variety of innovative projects.The RoleConduct thorough localization testing on software and hardware interfaces to ensure quality and accuracy.Effectively report issues using internal tools and collaborate with international teams to resolve bugs.Develop...

  • External Manufacturing QA Specialist

    2 weeks ago

    Cork, Cork, Ireland beBeeQuality Full time €70,000 - €110,000

    Job OverviewWe are seeking a skilled External Manufacturing QA Specialist to provide support to all quality activities at Contract Manufacturing organizations (CMs). The ideal candidate will be responsible for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory...