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 & Approval, and Quality Metrics Reporting.

This role requires a solid understanding of quality assurance systems, current Good Manufacturing Practices (cGMPs), and standard QA procedures. The ideal candidate is proactive, detail-oriented, and able to exercise sound judgment within established protocols and guidelines.

Key Responsibilities:

- Participate in inter-departmental and cross-functional teams.

- Author site contributions to Annual Product Quality Reviews and coordinate with global teams.

- Conduct counterfeit assessments related to product complaints.

- Investigate customer complaints in a timely and thorough manner.

- Collect and report on quality metrics.

- Contribute to the authoring, reviewing, and approval of Standard Operating Procedures (SOPs) and other controlled documents.

- Conduct QA walkthroughs to ensure site compliance with GMP requirements.

- Work on routine assignments, recognizing deviations from standard practices.

- Apply judgment within defined procedures to determine appropriate courses of action.

- Operate independently on routine work, with general guidance for new assignments.

Qualifications and Experience:

- Minimum of 2 years of relevant experience in a GMP-regulated environment.

- Bachelor's degree in a scientific or related field.

- Previous experience in the pharmaceutical industry, ideally within a QA function, is preferred.

- Strong working knowledge of cGMPs and quality systems (FDA / EMA standards).

- Familiarity with OPEX Lean tools and root cause analysis methodologies.

- Demonstrated skill in audits, investigations, and technical report writing.

- Proficiency in Microsoft Office applications (Word, Excel, Outlook, PowerPoint).

- Excellent communication skills, both written and verbal.

Preferred Personal Attributes:

- Positive and proactive mindset.

- Resilient and adaptable in dynamic environments.

- Ability to engage with multiple stakeholders to meet objectives.

- Curious, with a strong desire to learn and improve.

- Demonstrates operational excellence and a systematic approach to prioritization.

- Process-oriented with a focus on achieving high-quality outcomes.

Core Values Expected:

- Integrity – Always doing the right thing

- Teamwork – Collaborating effectively and in good faith

- Excellence – Committed to high performance and quality standards

- Accountability – Taking ownership of responsibilities and outcomes

- Inclusion – Embracing diversity and fostering a collaborative environment

#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 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

    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...