Manufacturing Excellence Specialist

4 weeks ago


Singapore RECRUIT EXPRESS PTE LTD Full time
Job Summary

We are seeking an experienced Deviation Writer to join our Manufacturing Engineering team in a regulated GMP environment. The ideal candidate will possess strong technical writing skills, excellent interpersonal abilities, and a deep understanding of industry-standard electronic Quality Management Systems.

This is a critical role that requires the ability to translate complex technical events into clear, accurate, and robust investigations. The successful candidate will work closely with cross-functional teams to create comprehensive investigations that leverage facts and data to support root cause conclusions, effective corrective actions, and systematic preventative measures.

Key Responsibilities
  • Understand, investigate, and author deviating conditions or nonconforming events across multiple technical departments, in alignment with Subject Matter Experts.
  • Analyze information, interpret data, and utilize expertise from Subject Matter Experts to provide supportive evidence for investigations and root cause identification.
  • Utilize various analysis tools, such as Ishikawa Fishbone and 5 Why, to support root cause identification and develop robust corrective and preventative actions.
  • Demonstrate a strong ability to critically think outside the box and leverage automation and engineering controls to error-proof equipment and processes.
  • Translate complex technical processes and descriptions into simplified, understandable write-ups that meet regulatory requirements.
Requirements
  • Bachelor's degree in a scientific, engineering, or technical discipline.
  • Minimum of 3 years of experience in technical writing within a regulated GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries.
  • Proficient in writing clear, concise, and accurate technical documentation.
  • Strong understanding of GMP manufacturing processes and regulatory requirements.
  • Excellent organizational skills with high attention to detail.
  • Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences.
Estimated Salary: $80,000 - $110,000 per annum

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