Quality Assurance Specialist New

3 hours ago


Portlaoise, Ireland CPL Full time

JO-2410-542775

Quality Assurance Specialist - NPI Projects

Reporting to the site QA Manager

Midlands – Co Laois, commutable from Offaly, Kildare, North Tipperary and surrounds.

CPL are working with our client partner to hire an experienced Quality Assurance Specialist for their GMP certified chemical production facility in Laois. The plant has been purpose built to support their client portfolio who are primarily in the Bio- Pharma, General Pharma and API manufacturing industries. Due to increased business, they require a QA Specialist to support a variety of commercialization/ NPI projects on-site

Role

- A key member of the product commercialization/NPI team.
- Lead the quality processes and product validation processes for product commercialization/NPI (New Product Introduction).
- Responsible for evaluating new and current processes to determine validation/verification requirements.
- Responsible for risk assessing new/current processes.
- Ensure adequate controls are in place to ensure product quality and reduce risk of non-conforming product.
- Manage project related non-conformances’ and providing support to all other departments in relation to investigation of issues identified as part of projects.
- Responsible for managing and supporting project related CAPA’s.
- Provide QA decisions for Product Commercialization Process.
- Responsible for updating/creating/review and approval of validation protocols and reports.
- Responsible for meeting agreed timelines for product commercialization/NPI projects.
- Review packaging specifications ensuring product contact packaging meets customer, regulatory and compatibility requirements. (i.e., leachable, extractables)
- Responsible for label management for new products.
- Provide regular project updates to management
- Responsible for escalating QA concerns/issues/challenges to QA Manager

Requirements

- Experience in a Quality Assurance role supporting NPI project required.
- Experience in a regulated environment.
- Previous GMP experience essential



  • Portlaoise, Ireland CPL Full time

    NEW ROLE : NPI Quality Assurance Specialist required for an established Pharma related manufacturing company in Laois. Our client offers a full range of products to the pharma/bio pharma and biotech sector in Ireland. Reporting directly to the QA Supervisor, the QA Specialist will support the Quality Management System, ensuring compliance with established...

  • (Urgent Search) Risk

    21 hours ago


    Portlaoise, Ireland REACH INTERNATIONAL INC Full time

    Risk & Quality Assurance Senior Manager - Dublin, Ireland Dublin, Ireland | Permanent | Excellent Package The Company Reach International is working with this Global Accountancy firm to recruit a Risk & Quality Senior Manager for its Dublin, Ireland office. This role sits within the Risk Management area of the Assurance Group. The Role - Working with...

  • Quality Specialist

    1 day ago


    Portlaoise, Ireland Quanta Consultancy Services Ltd Full time

    Quality Specialist - Pharmaceuticals - Hybrid/Carlow, Ireland - 11-Months With worldwide demand for their life-changing oncology treatment increasing, one of our global pharmaceutical clients is looking for a Quality Specialist to join their team to support multiple capital projects taking place onsite in Leinster. This is a fantastic opportunity to work...


  • Portlaoise, Ireland Cpl Healthcare Full time

    NPI Quality Assurance Specialist required for an established Pharma related manufacturing company in Laois. Our client offers a full range of products to the pharma/bio pharma and biotech sector in Ireland. Reporting directly to the QA Supervisor, the QA Specialist will support the Quality Management System, ensuring compliance with established procedures...


  • Portlaoise, Ireland Quanta Consultancy Services Ltd Full time

    Automation Specialist - Dublin - 12-Month Contract How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes, then this is the assignment for you! Our client is currently seeking the skills of an automation specialist to join their team. Our client develops and delivers life-changing medicines...


  • Portlaoise, Ireland PE Global (UK) Full time

    PE Global is currently recruiting for a Manufacturing Process Specialist on behalf of our client based in Cork. Full Time 12 Month Contract POSITION SUMMARY Reporting to Operations Manager, this position is responsible for representing operations on capital project teams and supporting first line troubleshooting of the day-to-day activities within...


  • Portlaoise, Ireland Collins McNicholas Recruitment Full time

    Our Client, a globally recognized leader in healthcare innovation, based in Athlone, Co. Westmeath is seeking a Senior Regulatory Affairs Specialist. In this role, the candidate will take charge of managing regulatory activities and projects, developing regulatory strategies for new products, and handling submissions to regulatory authorities while...


  • Portlaoise, Ireland Quanta Consultancy Services Ltd Full time

    EHS Specialist - Onsite position - Carlow - 11-Months With worldwide demand for their life-changing oncology treatment increasing, one of our global pharmaceutical clients is looking for an EHS Specialist to join their team to support multiple capital projects taking place onsite in Carlow. This is a fantastic opportunity to work on a state-of-the-art...


  • Portlaoise, Ireland Life Science Recruitment Full time

    Associate QA Specialist (Shift) AMC20711 11 Months Carlow We’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...


  • Portlaoise, Ireland Quanta Consultancy Services Ltd Full time

    Graduate Lab Systems Specialist - Dublin - 12-Month Contract One of the top 10 best companies to work in Ireland is looking for a Lab Systems Specialist for their large-scale new facility in Dublin. Is this you? An exciting project with lots of opportunities to learn new technology and develop current skills within a fast-paced €1 billion project. This...


  • Portlaoise, Ireland Link Personnel Full time

    Our Client is a Multinational Manufacturer of Medical Devices and they have instructed us to hire a Material Quality Inspector for a 23-month contract. Salary: to €35,500 Benefits: Bonus, Parking, Flexible Hours, Subsidised Canteen Do you have: - Experience in quality inspection. - A third level qualification (Certificate/Diploma/Degree) in Quality...

  • Payroll Specialist

    1 day ago


    Portlaoise, Ireland Cpl Healthcare Full time

    One of Ireland's largest airlines is currently recruiting for a Payroll Specialist to join the Ground Ops Department of Europe's Favourite Airline! This is an exciting opportunity to join a very busy team. The successful candidate will be based in North Dublin offices near the airport. We are looking for people who are keen to learn and quick to adapt in...

  • Production Planner

    3 hours ago


    Portlaoise, Ireland CPL Full time

    Production Planner – Portlaoise An international Chemical Manufacturing facility is now hiring an experienced Production Planner for their growing team on their GMP site. Join our culture of inclusivity and innovation! Role: The Production Planner is primary responsible for scheduling short and long-term production activities to fulfill customer and...


  • Portlaoise, Ireland Amgen SA Full time

    Each Brainstorm Is a Chance To Save a Life That's how we live. We know an idea—any idea—can blossom into a lifesaving treatment. That’s why we dare to ask the questions most people won’t. Join us in pushing biotechnology. From our tech to how we work, everything we do is about putting patients first. Our curiosity, energy, and optimism motivate us...


  • Portlaoise, Ireland ICDS (UK) Ltd Full time

    Site Manager North Dublin, Swords €80-90k + Transport + Package Required for medium-sized contractor Irish Contractor who are currently undertaking a large new build mixed-use project in Swords, North Dublin, circa €60m. Role - Liaising with consultants, subcontractors, supervisors, planners, quantity surveyors and the general workforce involved in...


  • Portlaoise, Ireland Quanta Consultancy Services Ltd Full time

    Laboratory Systems IT Engineer - Pharmaceuticals - 12-Month Contract Are you local to Ireland and looking for your next contract assignment? Our client, a leading pharmaceutical organisation, is recruiting for a Laboratory Systems IT Engineer to join their newly assembled team and help contribute towards the development of their next core...


  • Portlaoise, Ireland APOTEX Full time

    Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is...


  • Portlaoise, Ireland Life Science Recruitment Full time

    We’re currently recruiting for an exciting opportunity with a 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 - Be a document system expert; this will include document review, approval and document system work flow...

  • Site Engineer

    1 day ago


    Portlaoise, Ireland ICDS (UK) Ltd Full time

    Site Engineer (Senior) | Dublin & Leinster c.€75k (all-in), Car, Pension & Benefits Recruiting a high calibre Senior Site Engineer, to assist in the provision of civil engineering services for high- and low-density housing and apartment developments in the GDA (Greater Dublin Area) under the direction of the Project Manager/Site Manager. Key...


  • Portlaoise, Ireland Cpl Healthcare Full time

    Cpl Healthcare is currently seeking applications for the role of Clinic Manager for a specialist renal clinic in Wexford. Working for one of the world’s leading healthcare suppliers, the successful applicant will manage and lead the nursing & support teams in the care of patients with renal failure, which has been established to supplement and support the...