QC Analyst

  • Dublin South
  • Temporary 12 months
  • JO-1906-64597_1561622953

Summary

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.

Responsibilities

  • 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

Requirements

  • 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

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