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QC Technical Specialist

  1. France
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
14-09-2023
31617
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QC Technical Specialist – Biopharmaceutical – France

One of our global Gene Therapy clients is looking for a QC Technical Specialist to join their team close to Hombourg, France.

For 10 years, our client has been at the forefront of pioneering gene therapies, blazing new trails in the field. Their focus lies in crafting personalised investigational therapies, each meticulously designed to target the root cause of diseases at the genetic level.

Responsibilities include:
  • Provide oversight of in-process, release test and stability methods at external CTO(s) to support quality control testing for molecular, cell-based, and immunological-based test methods utilised in release, in-process and stability testing,
  • Support authoring and approval of external protocols, reports, SOP’s, and technical assessments in support of method life-cycle activities at CTO’s,
  • Ability to monitor analytical method performance, including statistical data analysis for method performance monitoring and reporting and assessment of analytical method system suitability requirements.
  • Assist in remediation of methods and studies based on trends or other method-based investigations.
  • Assist with quality systems records required for change controls, deviations, laboratory investigations, CAPAs and out-of-specification (OOS) related to method implementation or method performance,
  • Support assay monitoring focused on assessment of method performance, including re-evaluation of system suitability requirements and design of method robustness studies, 
  • Ensure all documentation comply with cGMP regulations and industry guidelines
Key requirements include:
  • BS or MS in a scientific discipline, 8-10 years of related laboratory experience in QC GMP environment in a commercial environment
  • Experience in cell-based bioassays (such as potency assays), molecular biology (such as qPCR), ELISA, and/or biochemistry
  • Strong track record of interpreting cGMP/ICH/FDA/EU regulations
  • Experience with the set up or expansion of a laboratory and equipment validations IQ/OQ/PQ
  • Experience with and good understanding of statistical software packages such as JMP
If this role is of interest, please apply now!

The candidate must have the rights to work in the location stated in the job advert.

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