API Manufacturing Specialist

3 days ago


Singapore ONE STOP ENGINEERING PTE. LTD. Full time
Job Overview

We are seeking a highly skilled API Manufacturing Specialist to join our team at ONE STOP ENGINEERING PTE. LTD.

Salary: SGD 80,000 - 120,000 per annum, depending on experience.

Key Responsibilities
  • Setting up Electronic Batch Records: Establish and maintain electronic batch records, ensuring accuracy and compliance with regulatory requirements.
  • Manufacturing Process Technical Support: Provide technical support and guidance to manufacturing teams to improve process efficiency and product quality.
  • Equipment Validation and Qualification: Support start-up and assist in plant equipment and facility validation and qualification activities.
  • Technology Transfer: Support manufacturing activities during technology transfer, qualification, and validation batches associated with new product introductions.
  • Operational Efficiency: Support operational efficiency goals for yield, product quality, and other product and/or site KPIs.
  • Troubleshooting: Contact and consultant for process/equipment troubleshooting and investigation activities.
  • Risk Assessment: Provides support for risk assessment activities, providing relevant technical knowledge.
  • Documentation: Authors technical reports, batch records, SOPs, investigations, protocols as required, ensuring consistency and quality of the group's documentation.
Requirements
  • Education: Chemical Engineering with >5 years of experience (preferably) in API Manufacturing or MSAT role.
  • Experience: Responsible for manufacturing support of commercial API processes, providing rapid response to operational issues, and supporting ongoing operations including new product introduction, process engineer, process flow diagrams, and process batch record authoring.


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