• Provide GMP/GDP quality assurance expertise for product development and commercialization
  • Ensure quality activities align with development stages and maintain adequate quality standards for medicinal products
  • Guide resolution of complaints, testing issues, deviations, and propose Corrective and Preventive Actions (CAPA)
  • Establish a quality risk management approach based on six sigma concepts
  • Manage activities for releasing active ingredients and commercial products, including document approvals and batch record reviews
  • Notify CMC team of potential quality issues, participate in meetings, and assist in GMP/GDP audits at third-party sites


  • University degree in Pharmacy, Chemistry, or a related technical/science field
  • 3-6 years of experience in pharmaceutical product development, quality control, analytical development, chemical production, or similar roles
  • 3-6 years of experience in quality assurance for drug substance and/or drug product
  • Knowledge of drug substance and/or drug product development, manufacturing processes, quality control, packaging, distribution, (c)GMP/GDPs, and ability to manage complex projects and prioritize tasks