Pharmaceutical Manufacturing Excellence/ Technical Writer/ Deviation Writing/ Manufacturing Exp[...]

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

An innovative firm is looking for a detail-oriented Deviation Writer to join its Manufacturing Engineering team. This role is essential for translating complex technical events into clear investigations, ensuring compliance with GMP standards. The Deviation Writer will work closely with various departments, utilizing strong analytical skills and industry knowledge to provide robust root cause conclusions and effective corrective actions. If you are self-motivated and possess excellent communication skills, this position offers a unique opportunity to make a significant impact in the pharmaceutical industry.

Qualifications

• 3+ years of experience in technical writing in a regulated GMP environment.
• Strong understanding of GMP processes and regulatory requirements.

Responsibilities

• Investigate and author deviations across multiple technical departments.
• Collaborate with internal and external stakeholders for comprehensive investigations.

Skills

Technical Writing

Deviation Writing

Root Cause Analysis

GMP Knowledge

Microsoft Office Suite

Collaboration

Problem Solving

Education

Bachelor’s degree in a scientific, engineering, or technical discipline

Tools

Electronic Quality Management System

Documentation Tools

Microsoft Word

Microsoft Excel

Job description

Pharmaceutical Manufacturing Excellence/ Technical Writer/ Deviation Writing/ Manufacturing Expert/ Deviation Writer (Jr/ Sr)

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.
• 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, please send your most updated resume to [e-mail].

Thank You.

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)