IPC Analyst

  • Cork
  • Temporary 12 months
  • JO-1905-64447_1556783449

Summary

Responsibilities
  • Achieves competency in laboratory methods and procedures.
  • Trains other QC analysts in laboratory methods and procedures when required.
  • Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.
  • Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
  • Writes, executes, reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
  • Performs routine and non-routine analytical testing activities.
  • Review and approval (where appropriate) of laboratory test results.
  • Ensures that testing and results approval are completed within agreed turnaround times.
  • Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.
  • Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
  • Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader and Manager.
  • Deals with non-conformances/ deviations in an accurate and timely manner.
  • Deputizes for the QC Team Leader as appropriate.
  • Maintains and develops knowledge of analytical technology as well as cGMP standards.
    In process control testing and activities to support the production units.


Requirements

  • A third level qualification of a scientific/technical discipline is required.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
  • HPLC experience
  • Builds strong productive relationships.
  • Demonstrates ability to work with teams and individuals
  • Asserts personal ideas and opinions using persuasion to influence others
  • Seeks opportunities to grow and develop professionally
  • Uses best practices to improve business operations
  • Holds self-accountable for compliant and flawless execution
  • Takes personal responsibility for decisions that successfully build customer value
  • Effectively manages and adapts to change
  • Demonstrates the courage to stand alone on ideas and opinions that differ from others
  • Listens effectively and remains open to other's ideas.
  • Works effectively with people that have diverse styles, talents and ideas
  • Maintains the highest standards of ethical behaviour

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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