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Associate Director - Quality Control

FPSG Connect
Job LocationGlasgow
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Role responsibilities:

  • Legal responsibility for QC for manufacturing and manufacturing directed release testing
  • Assess and advise on release specifications and / or reject raw materials Evaluation of batch records to perform QP release of interim Drug Substance
  • Approve and monitor internal and contract analysis testing
  • Approve characterization and release testing on manufacturing specifications
  • Ensure that out of specifications (OOS) and deviations are appropriately investigated and resolved
  • Ensure all manufacturing directed testing and Product testing is performed accurately and appropriately.
  • Review and approve assay validation protocols and reports
  • Participate in continuous improvement projects (Local and Global)
  • Prepare appropriate Standard Operating Procedures (SOP) and training modules when required and carry out the training.
  • Be a member of on-site management team and attendance at leadership meetings (Local and Global)
Who you are:
  • Degree, or equivalent, in relevant life science. Advance degree preferred
  • Eligible to be a permanent Qualified Person for commercial and Investigational products
  • Extensive hands-on experience in Quality Control
  • Proven experience at a senior level leading a QC function in a life science GMP/FDA regulated environment, such as pharmaceutical and biopharmaceutical devices and diagnostics.
  • Experience with common continuous improvement tools (e.g.six sigma).
  • Extensive knowledge of EU/US GMP/GLP and related standards
  • Technical experience of a wide range of biological testing techniques
  • Proven ability to lead change through an organization
  • Commercially aware
  • Knowledge of Quality Risk Management.
We are Disability Confident and neurodiverse aware. If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process

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