Mississauga, Ontario

Qualification consultant

Quality Specialist

Mississauga, ON
6 months contract to start

We are in the process of transferring an instrument from our Drug Development lab to the QC Chemistry lab and would like to discuss having a consultant to drive the qualification process.

The instrument is a capillary isoelectric focusing unit that is used to determine charge heterogeneity. We would need IQ, OQ and PQ executed preparation of other related documents as well. It is only one instrument for which we need full qualification (IQ = Installation Qualification, OQ = Operational Qualification and PQ = Performance Qualification).

We are basically looking at:

University degree in Engineering or Science.
Minimum 3 years of experience with Qualification/Validation/QA/QC in Pharmaceutical or Biotech environment
Strong knowledge of laboratory instruments
Knowledge of capillary isoelectric focusing units would definitely be a big plus
Empower software experience preferred
Knowledge and understanding of cGMPs, aseptic processing standards and biopharmaceutical industry guidelines
Must have strong organizational, presentation and technical writing skills
Successful performance in leading multiple projects

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