QA Specialist, External Quality

2 weeks ago

Dublin, Dublin City, Ireland TN Ireland Full time

Team Horizon is seeking a QA Specialist for External Quality for our client, who is a leading biopharmaceutical company based in Dublin. In this role, you will support ongoing quality assurance responsibilities in support of Contract Manufacturing oversight and quality systems.

Why you should apply:

  • This is an excellent opportunity to join a world-class manufacturing operation.
  • Opportunity for career progression.

What you will be doing:

  • Serve as Quality Assurance support and SME for Drug Substance, Drug Product, and Finished Product manufacturing, maintaining knowledge of industry standards and regulatory requirements to ensure compliance.
  • Providing oversight of GMP systems completed by CMOs and External Supply Chain functions related to Drug Substance, Drug Product, and Finished Product.
  • Provide oversight to continuous quality system improvements and support implementing improvements at CMOs in compliance, Preventive Maintenance, Deviation Management, and Change Control Programs.
  • Work closely to build relationships with contract manufacturers' quality personnel.
  • Collaborate with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs, and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events.
  • Responsible for reviewing contractor documents, i.e., Batch records, deviations, and change controls.
  • Approve specific standard operating procedures and controlled documents issued by contract manufacturing organizations.
  • Support contract manufacturing organization audits, including pre-approval inspections, as necessary.
  • Develop and issue quality metrics pertaining to the process quality activities.
  • Trend and analyze quality aspects of technical transfer activities to measure key performance indicators, identifying areas for continuous process improvements and risk mitigation.
  • Review and assess deviations, which includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up, and reporting/trending.
  • Review Corrective and Preventive Actions (CAPA), which includes tracking, follow-up, reporting/trending, and evaluating CAPA for effectiveness.
  • Represent Quality Assurance to guide various projects and technical meetings, as needed.
  • Responsible for documenting and reporting compliance issues to management.
  • Any other duties as required by management.

What you need to apply:

  • Must have experience/knowledge of drug substance, drug product, and finished product manufacturing processes in a cGMP environment.
  • Minimum of 3-5 years' GMP related experience in biopharmaceutical/pharmaceutical or related industry.
  • Experience working with contract manufacturing organizations.
  • Experience working on the floor in manufacturing and QA.
  • Ability to provide project leadership and guide the successful completion of Quality projects.
#J-18808-Ljbffr

  • Specialist-(Batch Release)-Multi Level

    1 week ago

    Dublin, Dublin City, Ireland QA Full time

    QA Specialist-(Batch Release)-Multi LevelMid-Senior level Not disclosed Ireland Limerick, County Limerick, Ireland15 days agoPerforms activities in support of disposition of product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.As a Typical Day May Include The...

  • QA Distribution Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland TN Ireland Full time

    QA Distribution Specialist - Life Science - Contract - DublinAre you looking for the chance to join a life-changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a QA Distribution Specialist to support the QA Distribution Specialist function.Located 15 minutes from Dublin Airport and just a short...

  • QA Distribution Specialist

    3 days ago

    Dublin, Dublin City, Ireland Quanta part of QCS Staffing Full time

    QA Distribution Specialist - Life Science - Contract - Dublin Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a QA Distribution Specialist to support the QA Distribution Specialist function. Located 15 minutes from Dublin Airport and just a...

  • External Quality Assurance Professional

    2 weeks ago

    Dublin, Dublin City, Ireland Team Horizon Full time

    Team Horizon is expanding its QA capabilities and is seeking a highly skilled External Quality Assurance Professional to join our team. In this role, you'll support ongoing quality assurance responsibilities in support of Contract Manufacturing oversight and quality systems.Responsibilities:Maintain knowledge of industry standards and regulatory requirements...

  • Quality Assurance Specialist– Technical QA

    2 weeks ago

    Dublin, Dublin City, Ireland Recruitment by Aphex Full time

    Quality Assurance Specialist – Technical QAPurposeThe Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.ResponsibilitiesProvide overall quality direction and oversight for...

  • Qa Specialist

    3 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Senior QA Specialist €29.42 p/h Reporting to the Senior Manager, QA Compliance, the Senior Specialist, QA Compliance will support supplier quality operations for the manufacturing site in Dublin 15.This is a contract position until 31 Dec 2025.Key ResponsibilitiesRelease incoming materials for use in manufacturing operationsSupport qualification of new...

  • External Supply QA Manager

    3 weeks ago

    Dublin, Dublin City, Ireland Amgen Full time

    Join to apply for the External Supply QA Manager role at AmgenDescriptionQuality and Compliance Oversight CMOs and alignment with CTA / Marketing Application.Key ResponsibilitiesBe an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development,...

  • QA Specialist

    4 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Senior QA Specialist€29.42 p/hReporting to the Senior Manager, QA Compliance, the Senior Specialist, QA Compliance will support supplier quality operations for the manufacturing site in Dublin 15. This is a contract position until 31 Dec 2025.Key ResponsibilitiesRelease incoming materials for use in manufacturing operationsSupport qualification of new...

  • QA Specialist

    2 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Senior QA Specialist€29.42 p/hReporting to the Senior Manager, QA Compliance, the Senior Specialist, QA Compliance will support supplier quality operations for the manufacturing site in Dublin 15. This is a contract position until 31 Dec 2025.Key Responsibilities1. Release incoming materials for use in manufacturing operations2. Support qualification of...

  • QA Specialist

    5 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Senior QA Specialist€29.42 p/hReporting to the Senior Manager, QA Compliance, the Senior Specialist, QA Compliance will support supplier quality operations for the manufacturing site in Dublin 15. This is a contract position until 31 Dec 2024.Key Responsibilities1. Release incoming materials for use in manufacturing operations2. Support qualification of...

  • QA Specialist

    6 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Senior QA Specialist€29.42 p/hReporting to the Senior Manager, QA Compliance, the Senior Specialist, QA Compliance will support supplier quality operations for the manufacturing site in Dublin 15. This is a contract position until 31 Dec 2024.Key ResponsibilitiesRelease incoming materials for use in manufacturing operationsSupport qualification of new...

  • QA Specialist in Game Testing and Quality

    7 days ago

    Dublin, Dublin City, Ireland Amazon Full time

    Job SummaryWe're looking for an experienced QA Specialist in Game Testing and Quality to join our team! As a key member of our QA department, you will be responsible for ensuring the highest quality standards in game development.The ideal candidate will have extensive experience in QA, specifically in the games industry, with a strong background in testing...

  • QA Specialist

    4 days ago

    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    QA Specialist - Dublin, Ireland - 12 Months ContractOne of the top 10 best companies to work in Ireland is looking for a QA Specialist for their large-scale new facility in Dublin. Is this you?An exciting project with lots of opportunity to learn new technology and develop current skills within a fast-paced €1 billion project. This fantastic client offers...

  • QA Specialist

    15 hours ago

    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    QA Specialist - Dublin, Ireland - 12 Months ContractOne of the top 10 best companies to work in Ireland is looking for a QA Specialist for their large-scale new facility in Dublin. Is this you?An exciting project with lots of opportunity to learn new technology and develop current skills within a fast-paced €1 billion project. This fantastic client offers...

  • QA Specialist

    5 days ago

    Dublin, Dublin City, Ireland Life Science Consultants (LSC) Full time

    LSC have a great contract opportunity for a QA Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 3+ years industrial experience and are ready for your next challenge, this could be...

  • QA Specialist New

    1 week ago

    Dublin, Dublin City, Ireland CPL Full time

    Senior QA Specialist€29.42 p/hReporting to the Senior Manager, QA Compliance, the Senior Specialist, QA Compliance will support supplier quality operations for the manufacturing site in Dublin 15. This is a contract position until 31 Dec 2024.Key Responsibilities• Release incoming materials for use in manufacturing operations• Support qualification of...

  • Quality Assurance Specialist with Swedish

    1 week ago

    Dublin, Dublin City, Ireland Wipro Technologies Full time

    We are seeking an experienced Quality Assurance Specialist to join our team at Wipro Technologies.As a Quality Assurance Specialist, you will be responsible for evaluating client interactions and providing feedback to call center agents through QMS.You will also conduct regular calibration sessions to ensure evaluations are aligned with business...

  • QA Lead Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Cpl Resources Full time

    Cpl, in partnership with SK pharmteco, is looking to hire a QA Lead Specialist on a 12 month contract, to join the team in the Swords Campus, North Dublin. ABOUT US? SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korea company...

  • Qa Lead Specialist

    1 week ago

    Dublin, Dublin City, Ireland Cpl Resources Full time

    Cpl, in partnership with SK pharmteco, is looking to hire a QA Lead Specialist on a 12 month contract, to join the team in the Swords Campus, North Dublin.ABOUT US? SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland.We are part of SK Inc., a Korea company with...

  • External Quality Assurance Specialist

    2 days ago

    Dublin, Dublin City, Ireland Team Horizon Full time

    Team Horizon is a leading biopharmaceutical company based in Dublin, seeking a talented individual to fill the role of External Quality Assurance Specialist.About the RoleThis exciting opportunity involves supporting ongoing quality assurance responsibilities in Contract Manufacturing oversight and quality systems. As a key member of our team, you will be...