External Supply Operations & Analytical Science and Technology

Harvey Nash is looking for an External Supply Operationsleading programs and initiatives to implement changes and to remediate where required
- Interpreting stability data, analysing trends, and providing scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories; providing corrective actions to address immerging stability issues.
- Supporting Tech Transfer assessments for analytical method transfers.
- Supporting assessments of analytical Change Control records for acceptability; defining studies needed to support the changes.
- Ensuring Testing Monographs are state-of-the-art with respect to technique and technology, and in line with registration documentation; supporting programs and initiatives to implement changes to, and upgrading Testing Monographs where required
- Supporting analytical troubleshooting as needed
- Supporting implementation of Guidelines at external partners and suppliers

Requirements

- Education as a laboratory technician with focus on analytic or comparable education
- Languages: Fluent in speaking/writing in English
- 5-8 years' experience in the pharmaceutical industry
- Minimum 5 years experiences in QC environment or stability testing
- Experience in coordination of internal and external partners
- Thorough knowledge of cGMP requirements.
- Thorough knowledge of cGMP, ICH guidelines, regulatory requirements & risk management.

Are you available immediately, have experience working within a Life Science company?

Please send your complete CV (Word documents preferred). For further details feel free to call me.

I am looking forward to receiving your application.