Senior Quality Systems Manager

5 days ago


Nenagh, County Tipperary, Ireland Pe Global Full time
Job Overview:

We are seeking an experienced Quality Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our products and processes, and will work closely with cross-functional teams to achieve this goal.

Main Responsibilities:

  • Ensure compliance with MMD policies, procedures, and guidelines
  • Develop and implement quality plans for major projects
  • Manage site inventory of Quality Agreements and ensure Quality Agreements are raised for all required relationships
  • Interact and communicate with SD&PM, relevant stakeholders, and external parties to ensure appropriate Quality Agreements are current, approved, on file, and retrievable
  • Manage the annual quality council schedule
  • Manage the monthly quality council agenda, minutes, and action follow-up
  • Supplier Change Evaluations - Quality Role Review and approve Supplier Change Evaluation documentation
  • Complete/Approve MDS updates post SCE approval Approve Supplier Transparency update change requests post SCE approval Generate quality/technical agreements with suppliers as appropriate
  • Participate in the investigation and review of any internal/external customer complaints in accordance with agreed lead-times
  • Participate in the investigation and review of any supplier complaints in accordance with agreed lead-times
  • Filing & Licence maintenance and Regulatory Requests follow-ups Review and ongoing maintenance of site licences Provide site documentation to support product filings in accordance with CMC requests
  • Review and verify documentation that may be used for submission to Pharm - CMC or other requester(s) for regulatory submissions/filings
  • Assure the accuracy and integrity of all data and information through a timely review program
  • Manage the segregation and disposition of all returned goods
  • Audit program Support the internal GMP walk-down and scheduled audits program Support hosting of site Regulatory Inspections


  • Nenagh, County Tipperary, Ireland PSC Biotech Ltd Full time

    Job DescriptionAbout 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...


  • Nenagh, County Tipperary, 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...


  • Nenagh, County Tipperary, Ireland Takeda Full time

    Description Job title: Quality Systems Specialist Location: IRL - Dublin Job Summary: The Quality Systems Specialist is responsible for ensuring that the Quality Management System (QMS) for Small Molecule products is compliant with regulatory requirements, is aligned with industry best practices and meets Takeda global expectations. This...


  • Nenagh, County Tipperary, Ireland Reperio Human Capital Full time

    Senior Systems Administrator 99414 Desired skills: Senior Systems Administrator, Project Engineer, Windows, Networking, VMware Senior System Administrator Tipperary, Ireland Salary: 65K+ Permanent I am currently looking to speak with senior IT engineers for the role of Senior Project Engineer for our client based in Tipperary. Prior...


  • Nenagh, County Tipperary, Ireland PE Global Full time

    Job Description">The incumbent operates as part of a self-directed team in carrying out day-to-day functions and assigning priorities.Monitors performance metrics to ensure that the CoE delivers on all responsibilities in line with business needs.Participates in departmental initiatives on improved compliance, quality systems, and cross-functional...


  • Nenagh, County Tipperary, Ireland RedChair Recruitment Full time

    We are seeking an accomplished Senior Quality Assurance Specialist to drive quality excellence in our leading food production facility in County Kerry.The ideal candidate will have a proven track record in implementing and managing a Food Safety Management System (FSMS), with a strong understanding of food safety standards and experience with regulatory...


  • Nenagh, County Tipperary, Ireland Nrg Bluewater Wind Full time

    Welcome to the intersection of energy and home services.At NRG, we're driven by our passion to create a smarter, cleaner and more connected future.Vivint Smart Home, an NRG owned company, is a leading smart home company in the United States, dedicated to redefining the home experience with intelligent products and services.We find purpose in proactively...


  • Nenagh, County Tipperary, Ireland Recruitment By Aphex Group Full time

    About the TeamWe are Recruitment By Aphex Group, a leading provider of staffing solutions in the pharmaceutical industry. Our team is dedicated to helping clients find top talent to drive their business forward.The OpportunityWe are currently seeking a Pharmaceutical Quality Systems Lead to join our team. In this role, you will be responsible for developing...


  • Nenagh, County Tipperary, Ireland RedChair Recruitment Full time

    RedChair Recruitment is seeking an experienced and proactive Quality Manager Lead to oversee the food safety and quality management systems on site.The successful candidate will report directly to the Operations Manager, playing a pivotal role in upholding and enhancing quality standards, ensuring compliance with industry regulations, and fostering a strong...


  • Nenagh, County Tipperary, Ireland RPG Recruitment Full time

    Job DescriptionRPG Recruitment is seeking a highly skilled Senior Quality Assurance Specialist to join our team in South Tipperary. In this role, you will be responsible for ensuring excellence in quality control and quality assurance across various projects.About the RoleOversight of quality assurance and control across multiple projectsDevelopment and...


  • Nenagh, County Tipperary, Ireland Wallace Myers International Full time

    We are looking for a Senior Software Quality Assurance Specialist to join our team at Wallace Myers International Recruitment Agency. The successful candidate will have expertise in LabVIEW / TestStand Software and will be responsible for creating test executives, recording results, documenting findings, and report writing using Microsoft software.About the...


  • Nenagh, County Tipperary, Ireland FRS Recruitment Full time

    About FRS RecruitmentWe are currently seeking an experienced Senior Network Engineer to join our team at FRS Recruitment. Our client, a leading multinational, requires someone with expertise in network infrastructure to join their Irish operational hub.Role Overview:This role will involve providing 2nd level support for daily network issues, managing alerts,...


  • Nenagh, County Tipperary, Ireland U.S. Venture, Inc. Full time

    Technical ResponsibilitiesThis is a unique opportunity to work as a Senior Backend Software Engineer and lead the development of full stack solutions. Your primary responsibilities will include:Designing, developing, and implementing complex features and systems.Providing technical leadership and mentoring junior engineers.Collaborating with cross-functional...

  • Quality Specialist

    4 weeks ago


    Nenagh, County Tipperary, Ireland Recruitment by Aphex Group Full time

    Quality Specialist Purpose The Quality Specialist Quality Systems supports the Quality Systems activities in the both the Drug Substance and Drug Product facilities. The Quality Specialist participates as a member of the Quality Systems Team. Responsibilities Sub System Ownership: Complete sub system ownership responsibilities as per the site System...

  • Quality Specialist

    1 week ago


    Nenagh, County Tipperary, Ireland PE Global Full time

    PE Global are currently recruiting for a Quality Specialist Quality Systems for our client site in Tipperary: 11 month initial contract Role Description The Quality Specialist Quality Systems supports the Quality Systems activities in the both the Drug Substance and Drug Product facilities. The Quality Specialist participates as a member of the Quality...


  • Nenagh, County Tipperary, Ireland CPL Full time

    About the RoleA leading pharmaceutical company in the industry is seeking a Quality Control Reviewer to ensure the accuracy, integrity, and compliance of quality control laboratory data. This permanent role offers excellent benefits and the opportunity to play a key part in maintaining regulatory standards.This position involves reviewing analytical data...

  • Quality Specialist

    5 days ago


    Nenagh, County Tipperary, Ireland Pe Global Full time

    PE Global are currently recruiting for a Quality Specialist Quality Systems for our client site in Tipperary: 11 month initial contract Role Description The Quality Specialist Quality Systems supports the Quality Systems activities in the both the Drug Substance and Drug Product facilities.The Quality Specialist participates as a member of the Quality...


  • Nenagh, County Tipperary, Ireland Merck Gruppe - Msd Sharp & Dohme Full time

    Job Overview:Invent solutions to meet unmet healthcare needs and drive one of the world's leading healthcare companies forward. As a Senior Quality Assurance Specialist, you will play a vital role in ensuring compliance with SOPs, GMP, and regulatory requirements.We are committed to 'Inventing for Life' in all that we do, keeping the patient at the heart of...

  • Quality Specialist

    6 days ago


    Nenagh, County Tipperary, Ireland Next Generation Full time

    Quality Specialist - Quality SystemsAre you passionate about quality and compliance in pharmaceutical manufacturing?We're looking for a Quality Specialist - Quality Systems to support quality assurance activities across both Drug Substance and Drug Product facilities.This is a key role ensuring compliance, process validation, and continuous improvement to...


  • Nenagh, County Tipperary, Ireland RPG Recruitment Full time

    About the JobWe are looking for a talented Engineering Quality Control Professional to join our team at RPG Recruitment. This role offers an exciting opportunity to contribute to the success of our mechanical and electrical engineering company based in South Tipperary.Main ResponsibilitiesOversee quality assurance and control across multiple projectsDevelop...