Technical Writer (Deviations
Summary
Write and maintain technical documentation for life-science manufacturing deviations, authoring investigation reports and SOPs that meet FDA/EMA standards.
Job Description:
- Contribute to Life Science projects for Antaes Asia clients
- Lead complex technical investigations into manufacturing deviations, non-conformances, and environmental excursions.
- Utilize structured Root Cause Analysis (RCA) tools (e.g., Fishbone, 5 Whys, FMEA) to identify underlying triggers.
- Author comprehensive investigation reports that withstand rigorous internal and external regulatory audits (FDA,EMA, etc.).
- Perform impact assessments on product quality, safety, and efficacy.
- Design and implement Corrective and Preventive Actions (CAPAs) to eliminate recurrence of deviations.
- Monitor the effectiveness of implemented CAPAs through data-driven metrics.
- Identify trends in manufacturing data to proactively suggest process improvements and "Right First Time" (RFT) initiatives.
- Provide real-time engineering floor support to troubleshoot equipment malfunctions or process drift.
- Collaborate with Quality Assurance (QA) and Production teams to ensure all activities align with Standard Operating Procedures (SOPs).
- Participate in the drafting and revision of SOPs, Batch Records, and Validation protocols.
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Job Requirements:
- Bachelor degree in Science, Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science
- 2 years’ experience in Engineering, pharmaceutical industry
- Strong understanding of cGMP, and global standards.
- Experience with process flow diagrams, technical illustrations, and instructional design
- Familiarity with Lean Manufacturing and Six Sigma principles.
- Knowledge of digital documentation tools and content management systems (TrackWise, VeevaVault).
- Strong documentation and technical writing skills.
- Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills