Added
22 days ago
Type
Full time
Salary
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data integrity gmp glp hplc capa

📋 Description

  • Support the transfer and validation of analytical test methods.
  • Implement and qualify new laboratory equipment, and maintain existing equipment per procedures.
  • Ensure laboratory documentation and computerized systems comply with data integrity policies and
  • Provide technical input during regulatory inspections to maintain compliance.
  • Review pharmacopoeia requirements and develop/update in-house lab procedures.
  • Generate and manage all analytical technical reports.

🎯 Requirements

  • At least 5 years of analytical experience in the pharmaceutical industry.
  • Third-level qualification in a relevant science discipline.
  • Proven track record in an analytical role.
  • Experience in GLP/GMP environment and knowledge of cGMP and EU/FDA/ICH/HPRA guidelines.
  • High level of expertise in analytical equipment, processes, and best practices.
  • SME-level knowledge of HPLC, Identification, Conductivity, Protein Concentration, Osmolality, and
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