QC Analyst

4 weeks ago

Dublin, Dublin City, Ireland CPL Healthcare Full time

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.

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