Summary
· The company is seeking an experienced and detail-oriented Deviation Writer to join our Manufacturing Engineering team.
· This role is crucial for translating a variety of complex technical events into clear, accurate, and robust investigations.
· The Deviation Writer will work closely with the Manufacturing, Production Engineering, Manufacturing Sciences and Technology, Supply Chain, Quality, and other cross-functional teams to create comprehensive investigations that leverage facts and data to support robust root cause conclusions, effective corrective actions, and systematic all-encompassing preventative actions.
· The Deviation Writer will exemplify excellent interpersonal skills and be capable of developing productive customer-centric working relationships with internal and external customers and have a role with high visibility to all departments.
· The Deviation Writer will have strong familiarity with industry standard electronic Quality Management System(s) and Microsoft Office suite products.
· They will thrive working autonomously utilizing strong self-management and organization skills but also be able to interact, collaborate, and lead within a team environment.
· The Deviation Writer will value the processes owned by internal customers and subject matter experts and will possess a demonstrated ability to support and influence positive outcomes in the application of that knowledge to wider processes.
Essential Job Functions:
· Understand, investigate, and author a variety of deviating conditions or nonconforming events across multiple technical departments, in alignment with Subject Matter Experts.
· Self-motivated to fact gather, analyze information, interpret data, utilize expertise from Subject Matter Experts, etc. in an effort to provide supportive evidence to the investigation and root cause.
· Experience utilizing a variety of analysis tools to support root cause identification; Ishikawa Fishbone, 5 Why, etc.
· Ability to 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 both internal and external stakeholders to comprehensively represent the facts of an investigation in a logical and presentable manner.
· Evaluating historical deviating conditions, adverse events, non-conformances, etc. in order to identify and prevent trends.
Special Job 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.
Additional Preferences:
· 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.
· Ability to manage multiple projects and deadlines simultaneously.
If you are interested in the position, do kindly drop your most updated resume to [email protected]
Thank You.
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
