QC Scientist

Harmonics Recruitment

Clare, Limerick

A leading pharmaceutical company based in Limerick is currently recruiting for an experienced QC Scientist to join their team. This is a permanent, full-time position giving the opportunity to join a select team that is leading the way in the pharmaceutical industry. Summary: Perform assay development, characterization, optimization, transfer, validation and investigation for QC chemistry group. Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development. Duties and Responsibilities : Performs assay development/validation for QC Chemistry or Biochemistry groups. Reviews new test procedures and assays. Evaluates and bring in new methodologies/techniques when needed. Facilitate assay transfer from R&D and to business partners. Organize analytical assay transfer internally and externally. Lead technical troubleshooting and problem investigation. Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance. Participates in training programs for analysts. Represent QC in project teams and provide Quality input across functional areas. Oversee Contract Laboratory testing. Position requires strong technical and troubleshooting skills in combination with strong communication skills in order to meet QC objectives. Requires approximately 30 to 40% of direct time in the laboratory. Write and review CMC sections for regulatory submissions. Education and Skills: Requires PhD in Biochemistry, Chemistry, Biology or related field, with 0-2 years of relevant experience / MSc in Biochemistry, Chemistry, Biology or related field with 3+ years’ relevant experience. Previous experience working in a GMP manufacturing environment is desirable. Excellent Communication skills, both verbal & written. Experience with electronic systems such as LIMS, SoftMax, Empower, Qumas, Trackwise etc., is an advantage. Adaptable and flexible, willing to travel when needed. Knowledge and proficient in the use of Microsoft products including, Excel, Word and PowerPoint. For more information on this position please contact Rachael O’Rourke on 061 336 136 or alternatively apply online. This job originally appeared on RecruitIreland.com.

2390 days ago