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quality assurance audits gxp capa change control
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📋 Description

  • Integrate local quality regulations for drugs, biologics, device and/or combination products and
  • Design effective quality systems, procedures and/or processes within cross functional teams to
  • Maintain and coordinate all Quality Management Activities for GDPMD/S for Singapore, and provide
  • Develop, manage, and implement quality principles to ensure effective compliance of the affiliate
  • Coordinate and investigate quality events such as deviations, nonconformities, complaints, and
  • Overlook affiliate redressing activities (e.g. overlabeling, redressing) to ensure compliance with

🎯 Requirements

  • Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other
  • 3+ years’ experience in quality assurance, quality oversight or relevant experience
  • Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process
  • Knowledge and familiarity with product, process, and both internal and external customer
  • Knowledge of QA systems and GxP compliance requirements including regulations and standards
  • Experience working in both team setting and independently. Works well with manager guidance to
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