QC Analyst - Dublin, Ireland - Cpl

    Cpl
    Cpl Dublin, Ireland

    Found in: beBee S2 IE - 1 week ago

    CPL background
    Description

    QC Chemistry Biosimilars Analyst

    Cpl in partnership with our client Pfizer are currently recruiting for QC Chemistry Analyst - Biosimilars:

    Pfizer Grange Castle is one of the largest integrated biotechnology plants in the world and is a key part of the Pfizer global manufacturing network. It is an innovative, exciting, and growing organization that has a range of products and state of the art technologies.

    Job Purpose:

    To maintain regulatory compliance through established programs for laboratory testing, maintenance, training, and SOPs within Quality Control Chemistry.

    Job Responsibilities:


    • Perform analysis on finished drug product, drug substance, in process materials and stability samples.


    • Ensure that sample analysis is conducted to meet batch disposition requirements.


    • Complete documentation associated with analytical results in a timely manner.


    • Report and document any non-conformances to the QC Team Lead.


    • Assist in the preparation and review of area documentation e.g. SOP's, Reports, Protocols.


    • Assist in the training of other analysts.


    • Ensure training compliance within assigned work area and QC.


    • Adhere to good laboratory practices and housekeeping standards.


    • Perform and assist in additional duties as directed by the QC Shift Lead.


    • Support any validation and qualification of test methods and processes.


    • Facilitate laboratory investigations and support associated product investigation.


    • Support Laboratory inspections and audits


    • Troubleshoot laboratory methods and instrument problems.


    • Establish and monitor trend analysis program.


    • Contribute to the operations of the Quality Control Laboratories.


    • Implement and adhere to appropriate levels of cGMP within the laboratory.


    • Promote safety awareness and the established culture of IIF within the assigned work area.


    • Participate and seek opportunities in the area of right first time and continuous improvement.

    Education/Experience:


    • 2+ years' experience working in QC Laboratory desired


    • Third level Qualification in Science, Engineering or equivalent is preferred though not essential. Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel)


    • Experience with Lab systems an advantage:


    • LIMS


    • Empower


    • TrackWise


    • PDOCs


    • Industry Experience in some or all of the following analytical techniques is desirable:


    • High Performance Liquid Chromatography (HPLC) with Empower


    • Capillary Gel Electrophoresis (CGE)


    • Imaged Capillary Electrophoresis (iCE)


    • UV Spectroscopy


    • Karl Fisher titration


    • Particulate Matter


    • Excellent communication and interpersonal skills

    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.