On-site QA Specialist

2 days ago

Tuas, Singapore WuXi AppTec Singapore Pte. Ltd. Full time $40,000 - $80,000 per year

Main Responsibilities:

  • Conduct on-site inspections of production workshops and warehouses to ensure compliance with GMP and relevant quality standards
  • Review and approve the release of raw materials, ensuring they meet quality requirements before use
  • Review and approve the release of packaging materials, ensuring compliance with specifications
  • Manage and issue cleaning records, ensuring traceability of the cleaning process
  • Review master cleaning records to ensure compliance and effectiveness of cleaning procedures
  • Handle cleaning deviations, coordinate with relevant departments for investigation and implementation of corrective actions
  • Review cleaning impact assessments to evaluate the potential impact of cleaning deviations on product quality
  • Participate in continuous improvement of the quality management system and promote on-site quality management
  • Maintain effective communication with production, warehouse, and quality-related departments to ensure smooth information flow

Qualifications:

  • Bachelor's degree or above, preferably in Pharmacy, Chemistry, Quality Management, or related fields
  • 1-3 years of experience in QA or production in the pharmaceutical industry,familiar with GMP and related regulatory requirements
  • Proficient in on-site quality management processes; capable of working communication in both Chinese and English
  • Strong communication and coordination skills with a team-oriented mindset
  • Detail-oriented, responsible, with strong problem-solving and analytical abilities

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