Senior Technical Documentation Specialist
5 days ago
About the Role
We are seeking an experienced Senior Technical Documentation Specialist to join our Manufacturing Engineering team in Singapore. As a key member of the team, you will be responsible for creating comprehensive investigations and technical documentation that support robust root cause conclusions, effective corrective actions, and systematic preventative measures.
Responsibilities:
- Investigate and author deviating conditions or nonconforming events across multiple technical departments, in alignment with Subject Matter Experts.
- Fact gather, analyze information, interpret data, and utilize expertise from Subject Matter Experts to provide supportive evidence to the investigation and root cause.
- Experience utilizing analysis tools such as Ishikawa Fishbone and 5 Why to support root cause identification.
- Critically think outside the box for robust corrective and preventative actions, leveraging automation and engineering controls to error-proof equipment and processes.
- Demonstrated ability to translate complex, technical processes and descriptions into simplified, understandable write-ups.
- Eagerness to collaborate and partner with internal and external stakeholders to comprehensively 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, 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.
- Familiarity with documentation tools and electronic document management systems (EDMS).
- Exceptional computer skills, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel.
Salary Information:
The estimated salary for this role is SGD $8,000 - SGD $12,000 per month, depending on qualifications and experience.
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