Manufacturing Technical Writer

3 days ago


Singapore RECRUIT EXPRESS PTE LTD Full time
Job Title: Senior Deviation Writer

At Recruit Express Pte Ltd, we seek to hire a skilled Senior Deviation Writer to join our team. This role is responsible for creating comprehensive investigations and technical documentation to support robust root cause conclusions, effective corrective actions, and systematic preventative measures. The ideal candidate should have experience in technical writing within a regulated GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries.

Key Responsibilities:
• Investigate and author deviating conditions or nonconforming events across multiple technical departments.
• Gather, analyze information, and interpret data to provide supportive evidence to the investigation and root cause.
• Utilize various analysis tools to support root cause identification and develop robust corrective and preventative actions.
• Translate complex technical processes and descriptions into simplified, understandable write-ups.
• Collaborate and partner with internal and external stakeholders to represent the facts of an investigation in a logical and presentable manner.
• Evaluate historical deviating conditions, adverse events, non-conformances, etc. to identify and prevent trends.

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.
• 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.
• Familiarity with documentation tools and electronic document management systems (EDMS).

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