IPC Analyst
Scientificjobs
Cork
4d ago

We’re currently recruiting for an exciting opportunity with an award-winning biopharmaceutical organization based in Cork.

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 competency in laboratory methods and procedures.
  • Trains other QC analysts in laboratory methods and procedureswhen required.
  • Performs analytical testing activities in relation to methodvalidation and technical transfer activities to ensure that allmethods meet ICH, USP and EP guidelines.
  • Executes validation, operation, maintenance, calibration andtroubleshooting of equipment and its associated software.
  • Writes, executes, reports and reviews IQ / OQ and PQ protocols toensure that all relevant equipment is qualified for cGMP use.
  • Performs routine and non-routine analytical testing activities.
  • Review and approval (where appropriate) of laboratory testresults.
  • Ensures that testing and results approval are completed withinagreed turnaround times.
  • Writes and reviews laboratory TMs, SOPs and WIs as directed bycompany policy.
  • Ensures QC activities are carried out in compliance with productlicense commitments, cGMP and company quality standards.
  • Is an active member of the QC group and provide assistance withother group activities as required and communicates relevantissues to the QC Team Leader and Manager.
  • Deals with non-conformances / deviations in an accurate andtimely manner.
  • Deputizes for the QC Team Leader as appropriate.
  • Maintains and develops knowledge of analytical technology aswell as cGMP standards.
  • In process control testing and activities to support the productionunits.
  • Education & Experience

  • A third level qualification of a scientific / technical discipline isrequired.
  • Knowledgeable of FDA / EMEA regulatory requirements applicableto biologics and / or pharmaceuticals.
  • Key analytical technique required : HPLC
  • Other desirable techniques : A280 and Nephelometry testing, residual protein assay, TOC analysis
  • Apply
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