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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

HPLC QC Consultant - Greece


Reference:SMC38505 Location: Republic of Ireland
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: MES Consultant, QC Analyst

We are seeking a detail-oriented Quality Control (QC) Consultant. The ideal candidate will have a strong background in High-Performance Liquid Chromatography (HPLC), stability testing, and a solid understanding of FDA and EU guidelines related to Out of Specification (OOS) results and HPLC testing. This role is critical to ensuring product quality and regulatory compliance.


Duties:

  • Conduct HPLC analysis of raw materials, in-process samples, and finished products to ensure quality and compliance with specifications.
  • Conduct stability testing on HPLC equipment
  • Perform stability testing and analysis to evaluate product shelf life and effectiveness.
  • Review and interpret data, ensuring accuracy and adherence to established protocols and regulatory requirements.
  • Investigate OOS results and prepare comprehensive reports, implementing corrective actions as needed.
  • Maintain up-to-date knowledge of FDA and EU regulations regarding quality control and laboratory practices.
  • Collaborate with cross-functional teams to support product development and quality initiatives.
  • Assist in the validation and calibration of analytical equipment and methods.
  • Ensure compliance with laboratory safety and quality standards.
  • Document all results and maintain detailed records in accordance with Good Manufacturing Practices (GMP).
  • Participate in continuous improvement initiatives to enhance laboratory efficiency and effectiveness.
Education and Experience :
  • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
  • Minimum 5 years experience in a QC laboratory, preferably within the pharmaceutical industry.
  • Strong expertise in HPLC and stability testing methodologies.
  • Knowledge of FDA and EU guidance on OOS and analytical testing.
  • Excellent analytical and problem-solving skills.
If interested in this posting please feel free to contact Sean McCarthy on +353 (0)85 813 6927 or [email protected] for further information.