Quality Control Analyst
RK2211
Greece


Job Summary:

We are seeking a detail-oriented Quality Control (QC) Analyst. 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 Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.