Quality Assurance Lead

4 days ago


Dublin, Dublin City, Ireland Endo Full time

About Us

">

Endo is a global leader in delivering life-enhancing products through focused execution. Our mission drives us to develop and deliver innovative solutions that improve patients' lives. We are committed to fostering a diverse, equitable, and inclusive workplace where talented individuals can thrive.

">

Job Description Summary

">

The Senior Quality Specialist leads an individual system and assists in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities. They provide quality guidance on product transfers and validations and ensure all activities related to manufacturing, packaging testing, release, and distribution of commercial products meet requirements in the U.S. market and other approved markets.

">

Key Accountabilities

">
  • ">
  • Quality Documentation/Reports Review:">
    • ">
    • Contributes to the preparation and/or review of annual product review and updates for regulatory filing(s), batch release metrics, and department reporting as applicable.">
    • Assists with decisions that require developing options to solve moderate to complex issues.">
    • Supports implementation and/or recommends internal/external business or compliance options and best practices to improve products, processes, or services.">
    • Prepares and/or reviews controlled documents (e.g., SOPs) required for compliance.">
    • Provides quality guidance on product transfers and validations and ensures all activities related to manufacturing, packaging testing, release, and distribution of commercial products meet requirements in the U.S. market and other approved markets.">
    ">
  • Quality Systems & Investigations:">
    • ">
    • Takes the lead in resolving investigations, deviations, and corrective actions, and other quality issues with each CMO.">
    • Leads an individual system and assists in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities.">
    • Contributes to and may lead operational teams in the development, management, harmonization, and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations, and company quality standards in support of cGxP activities.">
    • Assists with all aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events.">
    ">
  • Inspection Readiness:">
    • ">
    • Participates in cross-functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities, and special projects.">
    ">

Qualifications

">
  • ">
  • Bachelor's degree in a scientific-related field with a minimum of 5-8 years' relevant experience in a pharmaceutical, biopharmaceutical, or sciences industry.">
  • Master's degree in above fields with 3-6 years' relevant experience in a pharmaceutical, biopharmaceutical, or sciences industry OR">
  • Technical and quality background related to the sciences.">
  • Background in sterile manufacturing 1-5 years.">
">

Knowledge and Skills

">
  • ">
  • Strong knowledge of all current state, federal, and local US and EU standards and regulations (ICH, EU GMPs, US CFRs, ISO, etc.).">
  • Knowledge of 21-CFR-210, 21-CFR-211, and ICH Guidelines.">
  • Strong knowledge of the principles, concepts, and theories of the compliance/QA discipline.">
  • Strong verbal and communication skills required.">
  • Attention to detail required.">
  • Demonstrated excellent interpersonal skills and flexibility.">
  • Ability to handle multiple priorities in a fast-paced environment.">
  • Good writing skills.">
  • Strong organizational skills.">
  • Ability to build peer relationships.">
">

Commitment to Diversity, Equity, and Inclusion

">

At Endo, our diversity unites and empowers us as One Team. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity.

">



  • Quality Assurance Lead

    23 hours ago


    Dublin, Dublin City, Ireland Griffin Gaming Partners Full time

    We are seeking a Quality Assurance Lead to join our team at Griffin Gaming Partners. As a key member of the quality assurance department, you will be responsible for leading the development and implementation of test plans, coordinating testing efforts, and collaborating with cross-functional teams to ensure high-quality game releases.You will work closely...

  • Quality Assurance Lead

    23 hours ago


    Dublin, Dublin City, Ireland Eolas Recruitment Full time

    Job Title: Quality Assurance LeadAbout the Role:We are looking for an experienced Quality Assurance Lead to join our team at Eolas Recruitment. In this role, you will be responsible for providing mentorship and training to junior testers, while also identifying and mitigating risks related to software quality and performance.Key Responsibilities:Define,...


  • Dublin, Dublin City, Ireland Next Generation Full time

    Job Title: Quality Assurance LeadThe Next Generation is seeking a highly skilled Quality Assurance Lead to join their team. As a key member of the organization, you will play a vital role in ensuring the highest standards of food safety and quality management.About the Job:Oversee food safety and quality systems, guaranteeing compliance with BRC standards...

  • Quality Assurance Lead

    19 hours ago


    Dublin, Dublin City, Ireland Poutrix Full time

    Poutrix is seeking a Quality Assurance Lead to manage day-to-day QMS activities for their Country. This includes implementing, administering, and monitoring global QMS governance and tools in the country.Key ResponsibilitiesCoordinate the implementation of quality management system requirements and ensure compliance with established procedures.Develop and...


  • Dublin, Dublin City, Ireland Expleo Group Full time

    What We OfferWe offer a competitive salary and benefits package, as well as opportunities for career growth and development.In this role, you will have the chance to work with a talented team, contributing to the delivery of high-quality SAP EWM programme outcomes.The successful candidate will have a strong background in quality assurance, with experience in...


  • Dublin, Dublin City, Ireland Localizationacademy Full time

    Drive Excellence in LocalizationLocalizationacademy is seeking a seasoned Localization Quality Assurance Lead to join our team.About the Role:In this role, you will play a pivotal part in ensuring localization excellence, driving key initiatives across quality planning, assurance, and control processes.Responsibilities:


  • Dublin, Dublin City, Ireland Cpl Healthcare Full time

    RequirementsWe are seeking an experienced Software Quality Assurance Lead to join our team in Dublin, Ireland. As a key member of our global Product and Technology organization, you will be responsible for leading the quality assurance efforts for our software systems.Your primary responsibilities will include developing, implementing, maintaining, and...


  • Dublin, Dublin City, Ireland PCI Pharma Services Full time

    About the JobThe NPI Quality Assurance Lead will play a critical role in ensuring the quality of our products and meeting regulatory requirements.Key ResponsibilitiesManage the quality element of NPI for multiple projects and products.Develop and implement quality plans and procedures to ensure compliance with cGMP and regulatory requirements.Collaborate...


  • Dublin, Dublin City, Ireland TN Ireland Full time

    Quality Assurance Supervisor Job SummaryWe are seeking a highly motivated and experienced Quality Assurance Supervisor to join our team at Greencore. As a key member of our quality assurance team, you will be responsible for ensuring that all materials, including finished products, are safe and conform to all relevant specifications, legislation, and...

  • Quality Assurance Lead

    23 hours ago


    Dublin, Dublin City, Ireland Recruitment by Aphex Group Full time

    We are seeking a highly skilled professional to join our team as a Quality Assurance Lead. In this role, you will be responsible for leading investigations into fill/finish/inspection and packaging deviations, including:Establishing investigation teams and leading root cause analysis.Developing CAPAs and conducting product impact assessments.Documenting...


  • Dublin, Dublin City, Ireland LSC, Life Science Consultants Full time

    We are looking for a highly motivated and experienced Senior Quality Assurance Specialist to join our team in South Dublin. The ideal candidate will have 7+ years of experience working in the pharmaceutical or biotechnology industry and will provide overall quality direction and oversight for key functional areas.The Senior Quality Assurance Specialist will...


  • Dublin, Dublin City, Ireland Oradeo Full time

    **Job Description:**We are recruiting for multiple Safety and Quality Assurance Lead positions at all levels (Junior, Mid, Senior, and Director) on behalf of leading contractor companies operating in Ireland and across Europe.**Company Overview:**We are a leading recruitment agency specializing in placing top talent in various industries, including...


  • Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Job OverviewCpl Healthcare, in partnership with SK pharmteco, is seeking a Quality Assurance Lead Specialist on a 12-month contract to join the team in North Dublin. Our client is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities worldwide.About UsOur mission is to produce and deliver life-changing therapies...


  • Dublin, Dublin City, Ireland TN Ireland Full time

    Job Title: Quality Assurance and Process Improvement LeadAbout the CompanyTN Ireland is a leading organization dedicated to delivering high-quality services. We are committed to operational excellence and seek a talented individual to lead our quality assurance efforts.Key ResponsibilitiesDevelop and implement quality assurance frameworks to ensure...


  • Dublin, Dublin City, Ireland Vantage Full time

    Job Description:Vantage Resources is seeking an experienced Senior Quality Assurance Lead to lead and develop geo-dispersed QA teams for project delivery. This is a high-visibility, long-term digital banking program opportunity.The ideal candidate will have 10+ years in IT and 5+ years in Test Management, with strong expertise in manual & automation testing,...

  • Quality Assurance Lead

    23 hours ago


    Dublin, Dublin City, Ireland Eolas Recruitment Full time

    Welcome to Eolas Recruitment, where we are dedicated to delivering exceptional service to our clients. We are currently seeking a highly skilled Quality Assurance professional to join our team as a QA Team Lead.About the Job:This is an exciting opportunity to work on a hybrid work model with excellent career progression opportunities.The successful candidate...


  • Dublin, Dublin City, Ireland Blackfield Associates Full time

    Blackfield Associates is recruiting a Quality Director to join our team and lead our global quality programmes.Job DescriptionThis is a senior leadership role requiring a high level of expertise in Biologics, Gene Therapy, or Cryogenic Storage environments.The successful candidate will be responsible for developing and implementing a global quality assurance...


  • Dublin, Dublin City, Ireland Bausch & Lomb Ireland Full time

    Bausch + Lomb, a leading global eye health company, seeks a highly skilled Quality Assurance Manager to join its Dublin team. As part of our commitment to protecting and enhancing the gift of sight for millions worldwide, this role plays a critical part in ensuring the quality and compliance of our products.Key ResponsibilitiesManage the Quality Management...


  • Dublin, Dublin City, Ireland Expleo Full time

    OverviewThe Senior QA Manager is responsible for defining, implementing, and managing quality assurance strategies for SAP projects. This role requires a strong background in SAP quality assurance and project management, with experience in leading cross-functional teams and managing multiple projects simultaneously.Duties and ResponsibilitiesDefine and...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Are you an experienced quality assurance professional looking for a new challenge? We have an exciting opportunity for a Medical Device Quality Assurance Lead to join our team at Life Science Recruitment. Our client, a leading Medical Device organization based in Dublin, is seeking a highly skilled and experienced individual to support the development of...