Drug Product Manufacturing Engineer - Bukit Batok - ref. r33694523

apartmentWUXI XDC SINGAPORE PRIVATE LIMITED placeBukit Batok descriptionPermanent calendar_month 
Responsibilities
  • Responsible for the whole-process management of production materials, consumables, semi-finished products and finished products in strict accordance with GMP requirements
  • Mastery of the principles of DP equipment, familiarity with the production process, you may be able to operate equipment independently and perform basic maintenance of related equipment
  • In accordance with GMP requirements, draft and revise related operating procedures, batch production records and related files
  • Strictly adhere to change control and deviation investigation process, organize the drafts and implementation of changes, conduct deviation investigations, and establish corrective and preventive actions
  • Analyze and solve problems arising in the manufacturing process independently and understand how to contribute to solving problems and optimizing the process through literature review
  • Continuously optimize production processes and workflows to ensure production quality and improve production efficiency
  • Familiar with project production and transfer processes, capable of conducting gap analysis and project transfer
  • As a project lead, communicate internally and externally with other departments and clients to ensure the effective implementation of the project and solve the problems arising in the project
  • Participate in designing and recommending new plants
  • Participate in audits related to DP manufacturing
  • Adherence to company compliance requirements
Qualifications
  • Bachelor’s Degree with a major in any of the relevant disciplines: Pharmaceutical Manufacturing, Pharmaceutical Engineering, Pharmacy, Bioengineering, Biotechnology, Chemical Engineering, Microbiology, etc.
  • Knowledge of GMP is preferred, and expertise in aseptic production is an advantage.
  • Solid foundational knowledge in pharmacy and biotechnology, with proficiency in Microsoft Office.
  • Good English language skills, literature review skills, and a proactive approach to problem-solving in the workplace.
  • Strong hands-on operational ability, with careful and conscientious equipment operation and timely record-keeping.
  • Good communication and presentation skills.
  • Strong team collaboration, efficient execution, and a great sense of ownership.
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