Full Time Technical Writer (Deviations Jobs, Salary up to SGD 6,500 in ANTAES ASIA PTE. LTD. - Maukerja

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

Created in 2007 in Switzerland, Antaes is a consulting company, specialized in Information Systems and Organization.

Antaes is operating in Singapore since 2016 to initially accompany customers of the Financial Services industry. Our Financial Services team is a diverse consulting team, many recruited from the industry, combining in-depth knowledge of our clients’ businesses, technology, and consulting disciplines. We are providing our financial industry clients with Business Management & Information Systems services.

At Antaes Asia, we help our customers with:

• Business and IT Model transformation

• Legal & compliance

• Enhancement of client experience

• IT engineering

Antaes places people at the heart of the strategy, with a view to building loyalty and trust with our consultants and our partners. The talented people who join our teams are focused, empathic, responsive, driven, and resolutely turned toward new ideas.

Buidling on the same approach and thanks to expertise gained at the group level, Antaes Asia is now also active in other industries such as TelCo, Shipping, LifeSciences...