QC Analyst

4 weeks ago

Dublin, Ireland Cpl 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:

â¢Â Â Â Â Â Â Â Â Â Â Â Â Perform analysis on finished drug product, drug substance, in process materials and stability samples.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Ensure that sample analysis is conducted to meet batch disposition requirements.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Complete documentation associated with analytical results in a timely manner.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Report and document any non-conformances to the QC Team Lead.

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

â¢Â Â Â Â Â Â Â Â Â Â Â Â Assist in the training of other analysts.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Ensure training compliance within assigned work area and QC.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Adhere to good laboratory practices and housekeeping standards.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Perform and assist in additional duties as directed by the QC Shift Lead.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Support any validation and qualification of test methods and processes.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Facilitate laboratory investigations and support associated product investigation.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Support Laboratory inspections and audits

â¢Â Â Â Â Â Â Â Â Â Â Â Â Troubleshoot laboratory methods and instrument problems.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Establish and monitor trend analysis program.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Contribute to the operations of the Quality Control Laboratories.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Implement and adhere to appropriate levels of cGMP within the laboratory.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Promote safety awareness and the established culture of IIF within the assigned work area.

â¢Â Â Â Â Â Â Â Â Â Â Â Â Participate and seek opportunities in the area of right first time and continuous improvement.

 

Education/Experience:

â¢Â Â Â Â Â Â Â Â Â Â Â Â 2+ yearsâ experience working in QC Laboratory desired

â¢Â Â Â Â Â Â Â Â Â Â Â Â 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)

â¢Â Â Â Â Â Â Â Â Â Â Â Â Experience with Lab systems an advantage:

â¢Â Â Â Â Â Â Â Â Â Â Â Â LIMS

â¢Â Â Â Â Â Â Â Â Â Â Â Â Empower

â¢Â Â Â Â Â Â Â Â Â Â Â Â TrackWise

â¢Â Â Â Â Â Â Â Â Â Â Â Â PDOCs

â¢Â Â Â Â Â Â Â Â Â Â Â Â Industry Experience in some or all of the following analytical techniques is desirable:

â¢Â Â Â Â Â Â Â Â Â Â Â Â High Performance Liquid Chromatography (HPLC) with Empower

â¢Â Â Â Â Â Â Â Â Â Â Â Â Capillary Gel Electrophoresis (CGE)

â¢Â Â Â Â Â Â Â Â Â Â Â Â Imaged Capillary Electrophoresis (iCE)

â¢Â Â Â Â Â Â Â Â Â Â Â Â UV Spectroscopy

â¢Â Â Â Â Â Â Â Â Â Â Â Â Karl Fisher titration

â¢Â Â Â Â Â Â Â Â Â Â Â Â Particulate Matter

â¢Â Â Â Â Â Â Â Â Â Â Â Â 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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