Project QA Specialist

3 days ago

Tuas, Singapore WuXi AppTec Singapore Pte. Ltd. Full time $60,000 - $120,000 per year

Key Responsibilities:

  • Participate in the review of technical documents related to technology transfer, ensuring the transfer process meets quality requirements and is implemented smoothly.
  • Responsible for master batch record review to ensure related documents, processes, and procedures comply with company policies and regulatory requirements.
  • Execute batch record review, verifying production records for completeness, accuracy, and compliance.
  • Review quality standards and analytical methods to ensure their scientific validity and compliance with regulatory requirements.
  • Review process validation master plans (VMP), validation protocols, and validation reports to ensure validation activities comply with company and regulatory standards.
  • Lead change control and deviation management related to projects, driving deviation investigations, corrective actions, and preventive measures.
  • Responsible for product release, strictly controlling quality standards to ensure timely release of compliant products.
  • Host customer audits by preparing relevant documentation, coordinating onsite audit activities, and responding to audit inquiries to ensure successful audit outcomes.
  • Attend customer meetings to communicate project quality matters promptly, provide feedback on issues and improvements, and maintain good customer relationships.
  • Review deviation and investigation reports, ensuring reports are logically structured, data is detailed, and conclusions are clear.

Qualifications:

  • Bachelor degree or above in Organic Chemistry, Pharmaceutical Engineering, or related fields.
  • Relevant work experience is preferred; familiarity with pharmaceutical manufacturing and quality management regulations (e.g., GMP) is essential.
  • Clear thinking and rigorous logical reasoning skills, with proficiency in problem analysis and investigation report writing.
  • Strong communication and coordination skills, capable of effectively collaborating across departments to drive issue resolution.
  • Strong sense of responsibility, attention to detail, and good team spirit.
  • Fluent in both Chinese and English, capable of professional bilingual communication and report writing.

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