QC Scientist (Limerick)
|Title||:||QC Scientist (Limerick)|
|Sector||:||Scientific & Laboratory|
|Tel||:||+353 21 4297422|
Role of this position
- 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.
- Requires PhD in Biochemistry, Chemistry, Biology or related field, with 2+ years of relevant experience / MSc in Biochemistry, Chemistry, Biology or related field with 4+ years' relevant experience. Previous experience working in a GMP manufacturing environment is desirable.
- Experience with electronic systems such as LIMS, SoftMax, Empower, Qumas, Trackwise etc., is an advantage.
Please call Conor Twomey today for further information on 021 4297422 or email: email@example.com