Sr Associate QC

  • Dublin South
  • Temporary 12 months
  • JO-1905-64442_1556697466

Summary

The person appointed will join the QC Laboratory team. 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 of raw materials, in process, stability and finished product samples. Eg Ph, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing.
  • Review and authorisation of Lab Data
  • Support Analytical Technical Transfer activity testing reports and documentation.
  • Document review/updates when required.
  • Monitoring of site water and Nitrogen systems.
  • Equipment Calibration, Maintenance and Trouble Shooting.
  • Method Validation/Verification.
  • Training of QC Chemistry Laboratory colleagues.
  • Laboratory Investigation support
  • Laboratory Housekeeping and maintaining GLP standards.
  • Assisting in regulatory audits.
  • Commitment tracking and follow up

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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