Senior QA Specialist

3 weeks ago

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

A 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 working per week.

Responsibilities
  • Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and site-specific requirements.
  • Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
  • Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
  • Assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance.
  • Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies.
  • Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks.
  • Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement.
Qualifications & Experience
  • Degree in Science, Quality, or a related technical field.
  • 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
  • Strong written and verbal communication skills, capable of clearly articulating complex quality issues.
  • Logical thinker with the ability to remain proactive and composed under pressure.
  • Proven ability to work effectively both independently and collaboratively within a team.
  • Exceptional attention to detail and precision in preparing and reviewing GMP documentation.
  • Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms.
#J-18808-Ljbffr

  • QA Validation Specialist

    3 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

    3 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=""

  • Senior QA Specialist

    3 weeks ago

    Cork, Cork, Ireland PSC Biotech® Corporation Full time

    OverviewPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals...

  • QA Specialist

    3 weeks ago

    Cork, Cork, Ireland Catalyx Full time

    OverviewCatalyx 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.ResponsibilitiesDeliver Quality Assurance support to the Packaging Department.Evaluate and approve GxP documentation.Conduct Batch...

  • QA Specialist

    3 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

    3 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

    2 weeks 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

    3 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...

  • Gaming Qa Specialist

    3 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...

  • QA Specialist

    2 weeks ago

    Cork, Cork, Ireland GE HealthCare Full time

    OverviewIn this dynamic role, you'll take ownership of key Quality Assurance systems—including Deviations, CAPA, Change Control, customer complaints, GMP documentation, audits, training, and regulatory reports—driving continuous improvement and ensuring compliance with global standards. You'll be the go-to expert for system-related queries, lead data...