Development Center Analyst - Pharma

Mô tả Công việc

Routine Analytical Activities
- Mainly responsible for analytical technical parts, including: test method specification, project risk analysis…, coordination with third parties/vendors for the flawless execution of projects, report and escalation to project team as needed.
- Technical expertise and comprehensive understanding in method development, validation and transfer from raw materials to finished-good for new project. Conduct plan and execute the stability study until end of expected shelf-life.
- Cooperate with project team to provide/plan the appropriate timeline for testing plan, obtain proper resource allocation and mitigation plans for problems during the project lifecycle to ensure that most of projects will be delivered on-time, within scope and within budget.
- Prove his/her strive for result when participating in troubleshooting, investigation.

Other laboratory activities
- Participate to the routine activities of the laboratories: reference standard management, management list and document, calibration of analytical equipment, machine trouble shooting….
- Respect and apply all the requirements related to GLP.

Yêu Cầu Công Việc

• Bachelor of Chemistry or Pharmacist. The Master of Science is a plus.
• At least 2 years background in analytical technique, especially in the pharmaceutical industry.
• Good at using HPLC, UV spectrometer, and other instrumental analytical methods.
• Good knowledge of GLP and safety in chemical laboratory, good sense of international quality guidelines (WHO-GMP, ICH guidance...) and local drug regulations.
• Proficient skills for Microsoft Word, Excel and Powerpoint.