QC Analyst (Micro)

  • Cork
  • Temporary 12 months
  • JO-1902-64285_1551171408

Summary

Responsibilities

  • Achieves competency in laboratory methods and procedures.
  • Performs analytical testing activities in relation to material release.
  • 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 licence 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.
  • Maintains and develops knowledge of analytical technology as well as cGMP standards.


Requirements

  • A third level qualification in a scientific/technical discipline required, ideally Microbiology based.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals.
  • Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory.
  • A minimum of 2 years' experience in a laboratory-testing environment within the pharmaceutical industry would be an advantage.
  • Builds strong productive relationships
  • Demonstrate 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
  • Works effectively with people that have diverse styles, talents and ideas

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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