Quality Systems Specialist

4 days ago

Cork, Cork, Ireland PE Global Full time

The role:

PE Global is currently recruiting for a Quality Systems Specialist on behalf of a leading pharmaceutical company based in Cork. This is an initial 11-month contract and a shift role.

Description:

  • This position within the QA department will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan.
  • The Quality Specialist will have proven capability in development of Quality Systems as an active member, across cross functional teams, to deliver process improvement. The Quality Specialist will model the Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organisation.
  • The Quality Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership as required.
  • The role is a shift, full time onsite role providing quality oversight to Operational areas. This role is integrated in the production area. The shift is 5/2, week 1 is M/T/F/S/S all 11-hour days. Week 2 is W/T 11.30 hr days.

Responsibilities:

  • Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/ Investigations/ Change Management, environment monitoring programs; sterility assurance/low bioburden manufacturing; etc.
  • Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
  • Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality.
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  • Required to be proficient in Quality approval and oversight for Commissioning and Qualification activities (IQ/OQ/PQ).
  • Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
  • Makes decisions within guidelines and policies which impact Product Quality, Projects and Quality Systems.
  • Provides compliance contribution to project teams and leads small projects.
  • Coaches and guides colleagues within the site.
  • Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
  • Participate in GMP Walkthroughs.
  • Deviation Management & Change Control approval.
  • Ensures supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
  • Champion the highest Quality and Compliance standards for the site.

Education and Experience:

  • Degree or 3rd level qualification (Science, Quality).
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.
  • 5 years' experience in the pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
  • Quality Assurance SME knowledge, from both operational and educational experience, is required.
  • Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on or alternatively send an up to date CV to.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.***

Although it is not possible for us to respond to all applications, we at PE Global will do our utmost to give you feedback on your application. You have sent your CV into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your CV is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.

Skills:
quality systems, GMP, quality assurance, deviations, CAPAs


#J-18808-Ljbffr

  • Quality Systems Specialist

    3 weeks ago

    Cork, Cork, Ireland Quanta part of QCS Staffing Full time

    Quality Systems Specialist - Cork, Ireland - 11-Month Contract  One of our global Pharmaceutical clients is looking for a Quality Systems Specialist to join their team close to the picturesque and historical city of Cork. The site is renowned for manufacturing excellence and plays a vital role in the company's large-scale biotech operations worldwide. ...

  • Quality Specialist – Quality Systems

    4 weeks ago

    Cork, Cork, Ireland TN Ireland Full time

    Quality Specialist – Quality SystemsThe Quality Specialist – Quality Systems supports the Quality Systems activities in both the Drug Substance and Drug Product.Key Responsibilities:Timely and effective completion of the Quality Systems core functions in accordance with schedules and policies, procedures and guidelines.Sub system ownership...

  • Quality Systems Specialist

    3 weeks ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    11 Month contract On-site Cork Shift role 5/2 AMC22465I am looking for several Quality System specialists to join a growing team in a leading Pharmaceutical manufacturer in Cork.If you have 5+ years experience in QA roles in Pharmaceutical manufacturing with an in-depth knowledge of Quality Systems, this could be the role for youIn this role, you will...

  • Quality Systems Specialist

    2 weeks ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    11 Month contractOn-site CorkShift role 5/2AMC22465I am looking for several Quality System specialists to join a growing team in a leading Pharmaceutical manufacturer in Cork.If you have 5+ years experience in QA roles in Pharmaceutical manufacturing with an in-depth knowledge of Quality Systems, this could be the role for youIn this role, you will provide...

  • IT Quality Systems Specialist

    3 days ago

    Cork, Cork, Ireland TN Ireland Full time

    We are looking for a skilled IT Quality Systems Specialist to join our team at TN Ireland. As a Senior SAP Quality Assurance Manager, you will be responsible for ensuring the quality and reliability of IT solutions delivered by our company.Key ResponsibilitiesDefine, implement, and monitor quality standards, processes, and metrics.Provide technical guidance,...

  • Electrical Systems Specialist

    6 days ago

    Cork, Cork, Ireland Specialist Technical Services Full time

    About Us:Specialist Technical Services is a leading provider of electrical engineering, instrumentation, and design services across Ireland, UK, Europe, and the Middle East.We have expanded our scope to offer full-service solutions to renowned clients in various sectors, including Pharmaceuticals, Data Centres, Utilities, Oil, Gas & Chemicals, Food &...

  • Quality Management Systems Specialist

    13 hours ago

    Cork, Cork, Ireland Stryker Group Full time

    Job SummaryWe are seeking a highly skilled Quality Management Systems Specialist to join our team at Stryker Group. As a key member of our QMS team, you will be responsible for ensuring the effectiveness and efficiency of our quality management system.Key ResponsibilitiesEnsure compliance with internal and external regulatory requirements, including FGO,...

  • Technical Specialist for Electrical Systems

    7 days ago

    Cork, Cork, Ireland Specialist Technical Services Full time

    About UsWe are Specialist Technical Services (STS), a full-service provider dedicated to delivering exceptional electrical engineering, instrumentation, and commissioning services. Our expertise spans across Ireland, the UK, Europe, and the Middle East, with a strong presence in various industries.Job OverviewThe Electrical Engineer will be responsible for...

  • Quality Specialist

    1 day ago

    Cork, Cork, Ireland TN Ireland Full time

    Social network you want to login/join with:Quality Specialist - QMS - 28ph - Ballydine, TipperaryClient:Next GenerationLocation:Ballydine, TipperaryJob Category:OtherEU work permit required:YesJob Reference:894c027ad3d2Job Views:2Posted:24.03.2025Expiry Date:08.05.2025Job Description:Quality Specialist - Quality SystemsAre you passionate about quality and...

  • Quality Specialist

    2 weeks ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Quality Specialist Job OpportunityOur client, a long established and dynamic company providing professional services to the lifesciences sector, now has a really nice opportunity for a Quality Specialist to join their growing team.The role will involve ongoing maintenance of all quality standards (ISO, BRC, GMP+, ESAD etc.), management of the Vendor Approval...

  • Quality Systems Expert

    24 hours ago

    Cork, Cork, Ireland TN Ireland Full time

    Quality Assurance Role at BioMarinWe are seeking a Quality Assurance Specialist to join our team in Cork. As a member of our quality team, you will play a vital role in ensuring the quality of our products and services.You will be responsible for supporting quality systems, assisting with batch release process of drug product and pack label finished goods...

  • IT Support Specialist

    2 days ago

    Cork, Cork, Ireland Iron Systems, Inc Full time

    Job OverviewAt Iron Systems, Inc, we are seeking a highly skilled Technical Support Specialist to provide onsite and desk side support services to end users. As a key member of our team, you will be responsible for troubleshooting PC related problems and completing incidents within specified Service Level Agreements (SLA) in a pressurized environment.Key...

  • Operational Quality Specialist

    4 weeks ago

    Cork, Cork, Ireland TN Ireland Full time

    PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract...

  • Quality Assurance Specialist

    2 days ago

    Cork, Cork, Ireland TN Ireland Full time

    Job OverviewTN Ireland is seeking a highly skilled Quality Assurance Specialist to support the implementation and management of our food safety & quality management system.

  • Operational Quality Specialist

    2 weeks ago

    Cork, Cork, Ireland PSC Biotech Corporation Full time

    Job DescriptionAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...

  • Operational Quality Specialist

    5 days ago

    Cork, Cork, Ireland PSC Biotech Corporation Full time

    Job DescriptionAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...

  • Global Quality Assurance Specialist

    4 days ago

    Cork, Cork, Ireland Eli Lilly And Company Full time

    Eli Lilly And Company is a global healthcare leader headquartered in Indianapolis, Indiana. We are seeking a highly skilled Global Quality Assurance Specialist to join our team.The ideal candidate will have a strong background in quality systems and regulatory compliance. As a Global Quality Assurance Specialist, you will be responsible for ensuring the...

  • Technical Systems Specialist

    3 days ago

    Cork, Cork, Ireland Simotech Full time

    We are seeking a highly skilled Technical Systems Specialist to join our team at SimoTech. In this role, you will be responsible for leading the design and configuration of process control systems, providing technical guidance, conducting investigations, and resolving technical issues.Responsibilities:Lead the design and configuration of process control...

  • Operational Quality Specialist

    2 weeks ago

    Cork, Cork, Ireland PSC Biotech Ltd Full time

    About PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...

  • Operational Quality Specialist

    2 weeks ago

    Cork, Cork, Ireland PSC Biotech Full time

    Industry Pharma/Biotech/Clinical ResearchWork Experience 4-5 yearsCity CorkState/Province CorkCountry IrelandJob DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than...