- Perform IPC tests as per analytical procedure.
- Perform Lab tests and calculations and necessary reviewing of Lab records.
- Timely report lab issues of any case and ensure GMP compliance.
- Timely document the observations in case of Lab event, OOX and deviations and involve in the investigations if necessary.
- Involve the update the lab procedure, ensure execution.
- Use instruments as per Lab procedure, maintain Lab equipment as in good order, conduct preliminary trouble shooting, timely report instrument issues.
- Involve in the Lab management, maintain good working environment, ensure 5S and EHS requirements, ensure Lab safety and the safety of Lab staff.
- Communicate with TO and QC project management team. Ensure smoothness of the tests.
- Proactively study regulatory documents from various countries, such as BP, USP, JP, and EP, and refer to these documents when updating internal procedures.
- Participate in customer audits and government inspections, promptly address identified issues, and ensure GMP compliance.
- Timely track work progress, strengthen communication with internal and external clients, and establish stable and good relationships.
- Responsible for other tasks temporarily assigned.
- Team building: Assist department leaders in building a high-efficiency team.
- Diploma and above in Pharmacy or Chemistry related major
- Understand pharmaceutical production, testing, and quality management; familiar with GMP regulations
- Preferred to be proficient in English and Chinese, fluent in spoken English and Chinese to communicate with China and overseas internal and external stakeholders
- Good computer skills.
- Proficient in analytical testing and quality management, familiar with the structure and working principles of analytical instruments
- Familiar with industry laws and regulations regarding technical specifications for analytical operation
- Familiar with industry requirements for data integrity of analytical software; candidates with experience in computerized systems validation will be given priority
- Strong ability to handle on-site issues, with good coordination, communication, and execution skills;
- Detail-oriented, proactive, and able to work under pressure
- Ability to determine problems, gather information, understand facts, and draw correct and effective conclusions through scientific reasoning.
- Be able to adapt to night shift work
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Description
Work Responsibilities:
Requirement:
Others:
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