QC Specialist – QC Equipment Validationp

1 month 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 description is designed as a combined list of the general tasks expected of a QC Specialist – QC Equipment Validation. Personnel may be asked to perform some, or all of the tasks listed as required by the functional area. The contents of this document are not intended to be exhaustive and additional duties may be directed by the Team Lead and / or Manager.

Job Responsibilities:


• Execute all aspects of QC instrument and equipment validation support:


• New instrument and equipment validation (URS, IQ, OQ, PQ, Traceability Matrices, Summary Reports)


• Periodic review of instrument qualification packages as required.


• Routine QC support with respect to instrument issues


• Instrument and equipment validation scheduling


• Liaise with Vendors, Calibration, EHS, QA and QC to deliver instrument qualification and re-qualification schedules.


• Preparation and review of required validation documentation including protocols and reports.


• Ensure data integrity requirements are included and met as part of the qualification of new instrumentation.


• Establishment of procedures for management and maintenance of the validated system (data archive, project creation, security etc.).


• Generation of area and System Administration SOPs.


• Authoring, review and approval of qualification/validation protocols and reports, status reports, regulatory documents, and process descriptions.


• Completion of Security reviews, periodic reviews, compendial reviews and APQR sections as they relate to maintaining the qualified status of the system.


• Support the QC investigation process by providing accurate and concise information in a timely manner and raising investigations, where required, in QTS and eQMS.


• Participate in cross functional teams as required to provide support on, and resolution of, QC instrument and equipment validation requirements.


• Partner closely with customers and stakeholders to understand QC instrument and equipment validation requirements and escalate when necessary.


• Proactive engagement with customers and key stakeholders.


• Maintain the QC laboratories in a state of audit readiness at all times.


• Participate in new initiatives such as the 5S, Standard Work, Data Integrity and IMEX programs as they arise.


• Participate in and drive the continuous improvement of all aspects of the group.


• Ensure compliance with cGMP, corporate standards / Pfizer Quality System (PQS), site policies / procedures, and regulatory requirements.


• Technical writing assignments such as SOPs, trend reports, risk assessments, laboratory investigations, and change controls.

Education / Experience:


• You will be service orientated; delivery focused and can build rapport with key stakeholders both internal and external.


• Relevant Third level Qualification or equivalent (B.Sc. degree in science, engineering, quality, technical or other related life sciences or engineering discipline.


• 2+ years relevant experience in industry, preferably in a pharmaceutical or relevant GMP manufacturing environment.


• A strong knowledge and experience of validation or qualification experience with laboratory instrumentation, validation, and project lifecycle, ideally within a pharma / biopharma FDA regulated environment.


• Excellent communication and interpersonal skills.


• Proven experience in updating documentation and reports.


• Good working knowledge of IT systems and their interactions with laboratory instrumentation would be considered an advantage but not essential.


• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.

  • QC Equipment and Systems Team Lead

    3 weeks ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Did you know that your Internet Explorer is out of date?To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.Name:Surname:Email:Phone:Cv:Salary Expectations:Education:Experience:Current Location:Notice Period:Write here your cover note:If you would like us to create a jobseeker...

  • QC Digital System Specialist

    1 month ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in collaboration with Pfizer is looking for a QC Digital System Specialist to join the team on an 11-month fixed-term contract at their advanced facility in Grange Castle, Dublin.Role Overview:The QC Laboratory Digital Systems Specialist will lead initiatives for modernization and efficiency improvements at the Grange Castle site. They will liaise with...

  • QC Digital System Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in collaboration with Pfizer is looking for a QC Digital System Specialist to join the team on an 11-month fixed-term contract at their advanced facility in Grange Castle, Dublin.Role Overview:The QC Laboratory Digital Systems Specialist will lead initiatives for modernization and efficiency improvements at the Grange Castle site. They will liaise with...

  • QC Digital System Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in collaboration with Pfizer is looking for a QC Digital System Specialist to join the team at their cutting-edge facility in Grange Castle, Dublin for an 11-month fixed-term contract.Role Description:The QC Laboratory Digital Systems Specialist will spearhead modernization and resilience initiatives at the Grange Castle site by collaborating with...

  • QC Microbiology Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland Alexion Pharmaceuticals Full time

    This is what you will do: The QC Microbiology Specialist will be responsible for technical and quality oversight for activities within the QC Microbiology Department. The Specialist will provide technical support with regard to method verification. Environmental Monitoring, Utiliities and all other lab based activities. You will be responsible for: ...

  • QC Analyst

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    QC AnalystPermanentCpl in partnership with SK biotek Ireland are looking for a permanent QC Analyst to join the team in Swords Campus.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....

  • QC Analyst

    1 week ago

    Dublin, Dublin City, Ireland Cpl Full time

    QC AnalystPermanent Cpl in partnership with SK biotek are looking for a permanent QC Analyst to join the team in the Swords Campus. ABOUT US? SK biotek Ireland, an SK pharmteco company, is a global Contract Development andManufacturing organisation (CDMO) with state-of-the-art facilities in Korea,US, France and Ireland. We are part of the wider SK Inc. with...

  • QC Scheduler

    3 weeks ago

    Dublin, Dublin City, Ireland Alexion Pharmaceuticals Full time

    This is what you will do: The QC Scheduler will ensure effective utilization of laboratory equipment, facilities, and personnel. The QC Scheduler will be responsible for coordinating the ADMF laboratory's daily schedules, ensuring that all laboratory activities are efficiently planned and scheduled in coordination with the department's needs and...

  • QC Instrumentation Maintenance Specialist

    3 weeks ago

    Dublin, Dublin City, Ireland PSC Biotech Full time

    QC Instrumentation Maintenance Specialist Industry Pharma/Biotech/Clinical Research Work Experience 1-3 years City Dublin State/Province Dublin Country Ireland Job Description bout PSC Biotech Who we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India,...

  • QC Analyst

    3 weeks ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Meath. 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 Achieves a high level of competency in laboratory methods and procedures to support in process and...

  • QC Analyst

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl inpartnership is looking for a QC Analyst - Sample Management to join their team for a contingent fixed-term 11-month contract at their cutting-edge facility in Grange Castle, Dublin. Quality Control Sample Management Analyst Job Responsibilities: Routinely receive manufacturing test samples and distribute to the appropriate analytical...

  • QC Senior Analyst

    3 weeks ago

    Dublin, Dublin City, Ireland Alexion Pharmaceuticals Full time

    This is what you will do: Strong working knowledge of the cGMP QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis. Responsible for providing technical and laboratory support to the QC analysts in Alexion Dublin specifically working with the team as a trouble-shooter Possess the ability to understand and...

  • QC Analyst

    1 month ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership are looking for a Quality Control Analyst - Sample Management to join their team for a contingent fixed term contract at their modern facility in Grange Castle, Dublin.Responsibilities:Routinely handle manufacturing test samples and distribute them to the relevant analytical laboratories.Maintain procedures to ensure the chain of custody...

  • QC Analyst

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership are looking for a Quality Control Analyst - Sample Management to join their team for a contingent fixed term contract at their modern facility in Grange Castle, Dublin.Responsibilities:Routinely handle manufacturing test samples and distribute them to the relevant analytical laboratories.Maintain procedures to ensure the chain of custody...

  • QC Analyst New

    3 weeks ago

    Dublin, Dublin City, Ireland CPL Full time

    QC AnalystPermanentCpl in partnership with SK biotek Ireland are looking for a permanent QC Analyst to join the team in Swords Campus.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....

  • QC Chemistry Analyst

    3 weeks ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    QC Chemistry Analyst (Shift)RK2068311 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:Work as directed by the Quality Control Manager...

  • QC Technician

    3 weeks ago

    Dublin, Dublin City, Ireland Elk Recruitment Full time

    Position: QC TechnicianLocation: South KildareSalary: Excellent Package AvailablePerform all in-house QC testing on incoming raw materials, raw samples and /or finished products, working with minimal supervision.Receive instruction and guidance from QC Chemists and management. The position has internal contact with Production, and Purchasing and...

  • QC Chemistry Analyst

    1 week ago

    Dublin, Dublin City, Ireland GRIFOLS, S.A. Full time

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...

  • QC Analyst

    1 month ago

    Dublin, Dublin City, Ireland Takeda Pharmaceuticals Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • QC Chemistry Analyst

    3 weeks ago

    Dublin, Dublin City, Ireland Tandem Project Management Ltd. Full time

    Summary:Our client, a biopharmaceutical company based in Carlow, is hiring a QC Chemistry Analyst. The perfect candidate will handle analytical method transfers, validation, and commercial testing to facilitate the release of crucial drug products.Responsibilities:Follow instructions from the Quality Control Manager in line with company safety policies,...