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Details

QC Analyst (Separations Team)


Reference:CK/AHRM-131782 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst

Our client, a highly respected pharma company are looking for a QC Analyst to join their team in Cork. This position is to support the Separations team and will involve CIEF testing, HPLC and CSDS testing.

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 QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.

Basic Minimum Qualifications & Experience:

  • A third level qualification of a scientific/technical discipline is required.
  • Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
  • HPLC experience within a GMP environment is essential.