The position will involve working with the QC Chemical and Analytical Sciences (CAS) team to ensure all testing is performed as per regulatory requirements, cGMP and site procedures.
- Testing stability and finished product samples, Eg Ph, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing (Sub Visible, Protein Concentration and Polysorbate - preferred)
- Training of QC Chemistry Laboratory colleagues
- Document review/updates
- Peer-Review work
- Review and authorisation of Lab Data
- Possibility of testing of raw materials (not key focus, small part - however applicants will need some experience, Pharmaceutical Compendia)
- Support Analytical Technical Transfer activity testing reports and documentation.
- Monitoring of site water and Nitrogen systems
- Equipment Maintenance and Trouble Shooting
- Method Validation/Verification
- Laboratory Investigation support
- Laboratory Housekeeping and maintaining GLP standards
- Assisting in regulatory audits
- Bachelor's degree in a science discipline.
- 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
- Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products
- Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
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The Life Science Specialists