• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • North Valley Business Centre, Cork, T23 KC67, Ireland     +353 21 206 6178     info@prochem.ie
  • Quality Operations Laboratory Specialist – Co. Dublin

    Role Summary:


    • Our client, a globally renowned pharmaceutical company based in County Dublin have a fantastic opportunity for an experienced Quality Operations Laboratory Project Specialist.
    • The successful candidate will ensure all relevant QC documentation associated with the purchasing, introduction qualification and decommissioning of laboratory equipment and projects are complete to a high standard within the required time frames to facilitate business continuity for the QC Laboratories.
    • This is an 11-month contract role with strong possibility for extension.


    Core Duties and Responsibilities:


    • Attend all relevant project and equipment related meetings to give input on project status.
    • Responsible for setting up new equipment in LIMS and EAMS.
    • Assist with the coordination of the management of space within the QC labs with respect to equipment.
    • Assist with the decommissioning process for equipment to ensure that equipment is decommissioned in a timely manner to maximize the space available to the labs for the introduction of new equipment.
    • Work with Engineering to ensure that the Fixed Asset Register (FAR) is accurate and up to date, to include performing annual asset counts.
    • Drive process efficiencies tracking and reporting on improvements including cost, productivity and waste/rework as it relates to the management of projects and introduction of laboratory equipment.
    • Work with Engineering to ensure ready to use equipment tracker is accurate.
    • Trouble shooting common Quality Control instrumentation.
    • Write and generate PIRFs and Customer Requirement Documents (CRD’s) as necessary to allow Engineering to begin the purchasing process associated with each project or piece of equipment.
    • Complete Regulatory Assessment forms to aid with the categorization of qualification of new equipment.
    • Write the User Requirement Specification (URS) document for each piece of equipment or project required.
    • Write and raise change controls in the QTS system as required. (in project phase = QO Projs)
    • Present change controls at the change control forum for endorsement.
    • Drive projects to completion by working collaboratively with all parties to implement project deliverables to project plans.


    Minimum Qualifications and Experience:


    • Hold a B.Sc. degree in biological, /chemical sciences, business, or other related technical degree or equivalent experience in a regulated industry.
    • Preferable 2-4 years’ experience in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment.
    • Proven documentation skills with ability to generate text and write a document in a clear and unambiguous way, ensuring all relevant detail is covered.
    • Experience working with a documentation system e.g. PDOCs and an investigation/change control system e.g. QTS.
    • Demonstrated ability to successfully collaborate, influence and lead in a matrix organisation
    • Excellent communication and interpersonal skills
    • Proven record in demonstrating agility
    • Experience of involvement in technical issue resolution, in a multidisciplinary environment
    • Experience with trouble shooting Quality Control instrumentation.


    To Apply: Quote – PE22075


    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

    GC North Valley Business Centre, Cork, T23 KC67, Ireland.

    +353 21 2066178

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.