QA Specialist, External Quality

3 weeks ago

Dublin, Dublin City, Ireland TEAM HORIZON Full time

Team Horizon is looking for a Quality Assurance Specialist for External Quality for their client, a leading biopharmaceutical company in Dublin. As a part of this role, you will be responsible for supporting quality assurance tasks related to Contract Manufacturing oversight and quality systems.

Why consider this opportunity:

  • Join a top-notch manufacturing operation
  • Benefit from a Hybrid & Flexible working model
  • Opportunity for career growth

Responsibilities include:

  • Provide Quality Assurance support and expertise for Drug Substance, Drug Product, and Finished product manufacturing, ensuring compliance with industry standards and regulations
  • Oversee GMP systems implemented by CMO's and External Supply Chain function for Drug Substance, Drug Product, and Finished Product
  • Lead continuous quality system enhancements and assist in implementing improvements at CMO's related to Compliance, Preventive Maintenance, Deviation Management, and Change Control Programs
  • Establish strong relationships with quality personnel at contract manufacturers
  • Collaborate with various internal departments like External Plant Operations, CMO Management, CMC/Regulatory Affairs, and Technical Services to address issues promptly arising from record reviews and deviation events
  • Review contractor documents such as Batch records, deviations, and change controls
  • Approve specific standard operating procedures and controlled documents provided by contract manufacturing organizations
  • Participate in audits of contract manufacturing organizations, including pre-approval inspections
  • Develop and release quality metrics concerning process quality activities
  • Analyze quality aspects of technical transfer activities, identify areas for process enhancements, and risk management
  • Evaluate deviations, conduct risk assessments, participate in root cause analysis investigations, and track and report/trend findings
  • Review Corrective and Preventive Actions (CAPA), track effectiveness and report/trend results
  • Represent Quality Assurance in guiding projects and technical meetings as necessary
  • Document and report compliance issues to management
  • Perform any additional duties as required by the management

Requirements:

  • Experience and knowledge of drug substance, drug product, and finished product manufacturing processes in a cGMP environment
  • Minimum of 3-5 years of GMP-related experience in biopharmaceutical/pharmaceutical or a related industry
  • Experience with contract manufacturing organizations
  • Hands-on experience in manufacturing and QA roles
  • Ability to lead projects and ensure successful Quality project completion

  • QA Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland QA RESOURCES Full time

    QA Specialist (Associate Specialist, Specialist, Snr Specialist) Industry : Pharmaceutical Role Summary: The QA Specialist role participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities, Maintenance, Engineering, Materials Handling, and QA...

  • QA Specialist/Sr QA Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time

    In this role you will be responsible for providing QA oversight and support to manufacturing activities. Performs and leads activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. As a QA Specialist or Sr Specialist a typical...

  • QA Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Headcount Full time

    Quality Assurance SpecialistAn exciting opportunity is available for a Quality Assurance Specialist at a renowned Biotech company in Dublin. The QA Senior Specialist will play a crucial role in overseeing QA activities for QC laboratory and site operations. This includes providing quality oversight for equipment qualification, method transfer activities, and...

  • QA Specialist

    3 months ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl with our client Pfizer is looking for QA Specialist with lab equipment and computer systems validation experience. PurposeTo effectively guide the implementation of the Site ValidationActivities, working with the engineering, operations and QC teams to oversee the qualification and validation of the computer systems - CSV and lab area. Job...

  • Quality Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Independent Search Solutions Full time

    My client requires a Quality Specialist to join their Quality Team for a 12 Month Fixed Term Contract. Based in Galway City this leading Life Science & Pharmaceutical Firm has plans to expand its facilities in 2024 and will be looking to take on board an established Quality Specialist who has 3-5 Years' experience already working in a regulated environment...

  • Quality Specialist

    1 month ago

    Dublin, Dublin City, Ireland Independent Search Solutions Full time

    My client requires a Quality Specialist to join their Quality Team for a 12 Month Fixed Term Contract. Based in Galway City this leading Life Science & Pharmaceutical Firm has plans to expand its facilities in 2024 and will be looking to take on board an established Quality Specialist who has 3-5 Years' experience already working in a regulated environment...

  • QA Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Tandem Project Management Ltd. Full time

    Summary:A QA Specialist is required for a biotech company in Dunboyne. The incumbent will provide support for change control, deviation management and supplier quality management.Responsibilities:Participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.Participate in and lead...

  • QA Lead Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with SK biotek Ireland are seeking to recruit a QA Lead Specialist, on a permanent basis.ABOUT US? SK biotek Ireland, an SK pharmteco company, 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 the wider SK Inc. with revenues of $88...

  • QA Lead Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with SK biotek Ireland are seeking to recruit a QA Lead Specialist, on a permanent basis.ABOUT US? SK biotek Ireland, an SK pharmteco company, 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 the wider SK Inc. with revenues of $88...

  • QA Operations Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with SK biotek are looking to recruit a QA Operations Specialist on a permanent basis.ABOUT US?SK biotek Ireland, an SK pharmteco company, 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 the wider SK Inc. with revenues of $88 billion in...

  • QA Lead Specialist

    1 month ago

    Dublin, Dublin City, Ireland Cpl Full time

    ABOUT US? SK biotek Ireland, an SK pharmteco company, 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 the wider SK Inc. with revenues of $88 billion in 2022. Our mission is to 'make what matters for a healthy, happier world', from grams to tonnes. The...

  • QA Lead Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    ABOUT US? SK biotek Ireland, an SK pharmteco company, 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 the wider SK Inc. with revenues of $88 billion in 2022. Our mission is to 'make what matters for a healthy, happier world', from grams to tonnes. The...

  • Senior Specialist QA Scientific

    3 weeks ago

    Dublin, Dublin City, Ireland TEAM HORIZON Full time

    Team Horizon is seeking a Senior Specialist QA Scientific for our client based in Dublin. The Senior Specialist, Quality Systems, to join the Central Quality Systems and Compliance team. This role serves as a pharmaceutical quality subject matter expert and supports global colleagues across Operations, Commercial, Device, IT and Quality partners. The...

  • Senior QA Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Stemrp Full time

    STEM Recruitment Partners are working with a pharmaceutical company based in Dublin West, that is seeking a Senior QA Specialist to join their operations. 12 month contract initially, with strong likelihood of extension Up to €35-40/hour DOEFull time onsite. Job Responsibilities • Perform and evaluate trending of the Quality Management Systems to support...

  • QA Lead Specialist- Ireland

    3 weeks ago

    Dublin, Dublin City, Ireland SK biotek Full time

    About UsSK Biotek Ireland, a company under SK Pharmteco, is a global Contract Development and Manufacturing Organization (CDMO) with cutting-edge facilities in Korea, US, France, and Ireland. As part of the broader SK Inc. entity with revenues of $88 billion, our goal is to meet customer needs from small to large scale. The Swords Campus has been a pioneer...

  • QA Senior Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with SK biotek Ireland are looking for a Quality Assurance Senior Specialist on a permanent contract to join the Quality Team at the Swords Campus.SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part...

  • Quality Systems Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    On behalf of my client, a global pharmaceutical company, we are collaborating with them on a new hire for a Quality Systems Specialist.Permanent opportunity with hybrid option.Key responsibilities and reporting to the QA Compliance Manager: ·Support the ongoing management of electronic Quality Management Systems(eQMS) related, but not limited to the...

  • QA Operations Specialist – Ireland

    3 weeks ago

    Dublin, Dublin City, Ireland SK biotek Full time

    ABOUT US? SK biotek Ireland, an SK pharmteco company, 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 the wider SK Inc. with revenues of $88 billion in . Our mission is to , from grams to tonnes. The Swords Campus has led the way in the development,...

  • QA Senior Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Location:Swords CampusABOUT US?SK biotek Ireland, an SK pharmteco company, 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 the wider SK Inc. with revenues of $88 billion in 2022. Our mission is to 'make what matters for a healthy, happier world', from...

  • QA Senior Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland CPL Full time

    Location: Swords Campus ABOUT US? SK biotek Ireland, an SK pharmteco company, 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 the wider SK Inc. with revenues of $88 billion in 2022. Our mission is to 'make what matters for a healthy, happier world', from...