QA System and Validation

Found in: beBee jobs IE - 1 week ago


Dublin, Dublin City, Ireland Cpl Full time

The SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager.

Position Description:

The QA Systems Validation Specialist will be responsible for:


• Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.


• Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Including but not limited to:


• Qualification of premises, equipment and utilities.


• Computer system qualification.


• Laboratory equipment validation.


• Provide expertise in the area of validation ensuring compliance with current industry regulations, guidelines and trends.


• Participate in cross-functional project teams as the quality assurance validation representative.


• Review and approve the GMP design aspects of major capital projects including new facility construction, facilities upgrade, new manufacturing equipment and support systems.


• Communicate with all departments on site on a regular basis to ensure timely approval change controls to support the manufacturing schedule.


• Ensure all quality systems are implemented/executed in compliance with ICH Q7, Eudralex, 21 CFR and site Quality standards.


• Assist in the co-ordination of audit preparation.


• Review and provide input into the site periodic review and revalidation programme.


• Preparation, review and approval of GMP documentation.


• High level interaction with the various functions on site: Manufacturing, QC, Utilities and Engineering


• Participate in other projects as directed by the Quality Systems & Validation Manager.


• Strong interpersonal, communication and presentation skills are required for this position as well as good time management, multi-tasking and organisational skills.

Minimum Requirements:


• Min of BSc/BEng in Chemistry, Engineering or a science-related discipline with at least 3 years pharmaceutical experience ideally in a QA role. Preferably with experience in change control/documentation management, good manufacturing practices


• Knowledge / appreciation of other site operations such as QC, Operations, Engineering, IT.


• Some experience in Operational Excellence or project management would be desirable.

Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.


  • QA Validation Process Engineer

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    QA Validation Process Engineer Based within the QA department the QA Validation Process Engineer will be responsible for providing the company with technical and quality resources to manage the quality deliverables on projects, coordinate the necessary activities for ensuring the timely closure of internal/external quality issues and ensuring an effective...

  • QA Validation Manager

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland Pfizer Full time

    Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your...

  • QA Validation Specialist

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are currently recruiting for a QA Validation Specialist for an initial 11 months contract based in their Grange Castle Site. To provide a compliance overview of sitewide validation activities. To provide technical QA support to the Engineering function (including Automation), Technical Operations, Technical Services,...

  • QA Specialist

    Found in: beBee jobs IE - 2 weeks 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...

  • QA Officer

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland Viatris Full time

    QA Officer – Dublin Respiratory – 12 months agency contract page is loaded QA Officer – Dublin Respiratory – 12 months agency contract Apply locations Baldoyle, Dublin, Ireland time type Full time posted on Posted 10 Days Ago job requisition id R McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act...

  • technical qa tester

    Found in: beBee jobs IE - 3 weeks ago


    Dublin, Dublin City, Ireland Creative Heads, Inc. Full time

    Technical Qa Tester job at Larian Studios - Creative Heads, jobs for the right brains. Employers Start Here » Larian Studios Dublin - Ireland View all jobs at this company » TECHNICAL QA TESTER Description *This role is based in our Canada studio in Quebec City* With multiple awards to our name, Larian Studios has proven that we're dedicated to...

  • Validation Engineer

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland CPL Healthcare Full time

    Validation Engineer Our client is seeking a Validation Engineer to report directly to the Head of Quality, the Validation Engineer will be responsible for reviewing and issuing of validation protocols and reports and also the co-ordination of the execution of validation activities (process / cleaning and equipment and computer qualifications) with the...

  • Head of QA Management, Biotech

    Found in: beBee jobs IE - 4 days ago


    Dublin, Dublin City, Ireland GrabJobs Full time

    Job summaryHead of QA Management, Biotech Permanent contract Location: Dublin Job seniority: mid-to-senior level Responsibilities Promoting a Quality culture of Compliance Implementing KPIs within the Quality Assurance area Participating in production and site meetings Managing QA oversight of routine manufacturing Preparing and hosting internal and...

  • Equipment Validation Manager

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland Amgen Full time

    Equipment Validation Manager – Level 5The equipment validation department performs equipment validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing.The activities of the Equipment Validation Manager are to : Provides...

  • Principal Associate

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland eli lilly and company Full time

    Principal Associate - Computer Systems Quality Assurance page is loaded Principal Associate - Computer Systems Quality Assurance Apply locations Ireland, Limerick time type Full time posted on Posted 4 Days Ago job requisition id R-61388 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare...

  • Senior Validation Engineer

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland Cpl Full time

    Senior Validation Engineer One of the largest diabetes care companies in the world, is looking to add an experienced validation engineer to their team based in South County Dublin. This role will lead the validation team, managing the validation and Advanced Product Quality Planning lifecycle for the Dun Laoghaire site, including design transfer and the...

  • Sr. Associate

    Found in: beBee jobs IE - 3 weeks ago


    Dublin, Dublin City, Ireland eli lilly and company Full time

    Sr. Associate - Quality (Facilities, Maintenance, Utilities) page is loaded Sr. Associate - Quality (Facilities, Maintenance, Utilities) Apply locations Ireland, Limerick time type Full time posted on Posted 4 Days Ago job requisition id R-61263 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global...

  • IT Systems Administrator

    Found in: beBee jobs IE - 3 weeks ago


    Dublin, Dublin City, Ireland Collins McNicholas Recruitment Full time

    IT Systems Administrator will work with the Head of Information Technology, Head of People & Projects, and the internal teams, including Sales, Manufacturing, HR, Finance, Marketing and Customer Service, to support the company objectives and ensure all staff have the Information Technology hardware, software and user assistance they require to perform...


  • Dublin, Dublin City, Ireland State Street Full time

    Summary: This is a hands-on technical role requiring current experience working with large scale, cross-functional automation frameworks providing well-balanced coverage across UI, back-end integration and database levels. The candidate should be a sharp, experienced senior level automation engineer with strong problem-solving skills and a solid software...

  • Manufacturing Systems Engineer

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland Cpl Full time

    Manufacturing Systems EngineerThe Manufacturing Systems Engineer is to be primarily responsible for the delivery of the approved site programmes relating to manufacturing systems and technology development including, but not limited to, serialisation, automation improvements, sustainability, engineering systems and operations digitalisation and development...

  • Quality Control Specialist

    Found in: beBee jobs IE - 1 week ago


    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are seeking a Quality Control Specialist (NPI/ES/RMCR) to join the team for a 12month fixed term contingent contract, onsite at their state of the art plant in Dublin, Grange castle. Job Purpose:· Support the QC NPI and QCES and RMCR teams in the operational and analytical readiness of new products in and out of...

  • QC Specialist – QC Equipment Validationp

    Found in: beBee jobs IE - 1 week ago


    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are seeking a QC Equipment Validation specialist to join the team for an 11 month fixed term contract in their state of the art Dublin, Grange Castle Site. Job Purpose:This position is to provide support to Quality Control with instrument and equipment, Data Integrity, validation, and system administration.This job...

  • aws devops engineer

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland Cpl Full time

    I have an exciting new job for an AWS DevOps Engineer with my Global client who is a leading supplier in Information and risk management Solutions. They collect, validate and monitor supplier information provided by relevant vendors. Their customer base includes the aerospace, government defence and security industry.They are hiring a devops engineer to...

  • QC Digital System Specialist

    Found in: beBee jobs IE - 1 week ago


    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are seeking a QC Digital System Specialist to join the team for an 11 month fixed term contingent contract at their state of the art plant in Grange Castle, Dublin. Role Description:The QC Laboratory Digital Systems Specialist will drive modernization and robustness initiatives at the Grange Castle site by working...

  • Quality Systems Engineer

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland Collins McNicholas Recruitment Full time

    We are delighted to introduce a compelling opportunity to join our esteemed client in the medical device industry as a Quality System Engineer. Our client is a leader in the field, dedicated to producing high-quality medical devices and advancing healthcare. If you have a passion for quality assurance, a proven track record of excellence, and a...