QA Specialist, External Quality

2 weeks ago

Dublin, Dublin City, Ireland TEAM HORIZON Remote Work Freelance Full time
Team Horizon is seeking a QA Specialist for External Quality for our client, who are 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 Hybrid & Flexible working model 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 CMO's and External Supply Chain function related to Drug Substance, Drug Product and Finished Product. Provide oversight to continuous quality system improvements and supports implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs a Works closely to build relationships with contract manufacturers quality personnel Works closely 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 & change controls Approve specific standard operating procedures and controlled documents issued by contract manufacturing organisations Support contract manufacturing organisation audits, including pre-approval inspections, as necessary Develop and issue quality metrics pertaining to the process quality activities Trend and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness Represents 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 organisations. Experience working on floor in manufacturing and QA Ability to provide project leadership and guide successful completion of Quality projects

  • QA Distribution Specialist

    3 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 weeks 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...

  • QA Specialist

    1 week ago

    Dublin, Dublin City, Ireland Merck Gruppe - MSD Sharp & Dohme Full time

    Job DescriptionAn amazing opportunity has arisen for a QA Specialist at our R&D facility in Dunboyne. The QA Specialist is a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations.The QA specialist will be responsible for maintaining cGMPs for...

  • QA Specialist

    3 weeks ago

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

    QA Specialist - Life Science - Contract - ClonmelOur Partner in Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Clonmel for over 40 years, exports to over 25 countries around the world with primary...

  • QA Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland SK pharmteco Full time

    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 revenues of $99 billion in 2023. Our mission is to 'produce and deliver life-changing therapies that improve patient outcomes and save lives'. The SK pharmteco...

  • Quality Assurance Specialist

    4 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Quality Assurance Specialist Excellent opportunity for an experienced Quality Assurance specialist to work within our expanding supply chain team to develop our quality assurance activity.This new role will advance our QA program, working closely with our internal supply chain, compliance and product functions as well as external partners to develop our...

  • Senior QA Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Senior QA Specialist RK 3740 Contract – 12 months DublinWe're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Responsible for product release, ensuring products...

  • QA Lead Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl, in partnership with SK biotek, 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...

  • Quality Assurance Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Quality Assurance SpecialistExcellent opportunity for an experienced Quality Assurance specialist to work within our expanding supply chain team to develop our quality assurance activity. This new role will advance our QA program, working closely with our internal supply chain, compliance and product functions as well as external partners to develop our...

  • Quality Assurance Specialist

    1 week ago

    Dublin, Dublin City, Ireland CPL Full time

    Quality Assurance SpecialistExcellent opportunity for an experienced Quality Assurance specialist to work within our expanding supply chain team to develop our quality assurance activity. This new role will advance our QA program, working closely with our internal supply chain, compliance and product functions as well as external partners to develop our...

  • QA Lead Specialist

    3 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 Validation Specialist

    1 week ago

    Dublin, Dublin City, Ireland Hobson Prior Full time

    Hobson Prior is collaborating with a Biotech company who are in search of a Specialist in QA Validation. The chosen individual will offer supervision for the production and distribution of Gene Therapy medicinal products. They will be instrumental in guaranteeing that processes and equipment meet validation and qualification standards as per relevant...

  • QA Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with our client Pfizer are seeking a QA Specialist - Partner Change Control Coordinator to join the team for a 6 month fixed term contract, with Hybrid working at their state of the art Grange Castle Plant, Dublin West.Position SummaryThis is a temporary contract position for a 6-month term. The contract QA specialist/Sr. Specialist...

  • QA Specialist-(Batch Release)-Multi Level

    7 days ago

    Dublin, Dublin City, Ireland Regeneron Full time

    Performs 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 following:Preparing & reviewing of batch disposition documentation to support QP release of Formulated Drug SubstanceReviewing of QC...

  • QA Lead Specialist New

    2 weeks ago

    Dublin, Dublin City, Ireland CPL Full time

    Cpl, in partnership with SK biotek, 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...

  • QA Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland PE Global Full time

    The Role: PE Global are recruiting for a Manufacturing Specialist Investigations Lead to be based in Dun Laoghaire 12 Month initial contract - Hybrid Good technical writing for all deviation incidents, the team must write a thorough write up. So, the candidate must be comfortable with writing clear information and ensure it is detailed. Good project...

  • Qa Compliance Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Gertek Project Management Full time

    Ger TEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all...

  • Associate QA Specialist

    1 week ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Associate QA Specialist (Shift)AMC2071111 MonthsCarlowWe're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Duties:Review and approval of all manufacturing batch...

  • External Service Provider Quality Assurance Manager

    2 days ago

    Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    About the RoleThis role offers an exciting opportunity to oversee the implementation of top-notch quality standards, cutting-edge processes, and innovative tools and systems. As Associate Director External Service Provider QA, you will play a pivotal role in managing external service providers supporting Novartis Global Clinical Trials in R&D Quality,...

  • QA Systems and Validation Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    QA Systems and Validation Specialist(12 month Contract)Location: Swords CampusABOUT USSK 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 $95 billion in 2020. Our mission is to...