Responsible for the management of samples, reference standards, column and reagents.
Perform Lab procedures for the management of samples, reference standards column and reagents.
Timely report lab issues of any sample or reference standard and ensure GMP compliance.
Involve the update the lab operation procedure, ensure execution.
Use instruments as per Lab procedure, maintain Lab equipment as in good order, conduct preliminary trouble shooting, timely report instrument issues.
Timely document the observations in case of Lab event, OOX and deviations and involve in the investigations if necessary.
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.
Keep track of the progress of work in a timely manner, enhance communication with other internal departments, and establish stable and good relationships.
Responsible for other tasks temporarily assigned.
Assist department leaders in building a high-efficiency team.
Requirement:
Pharmacy or Chemistry related major
Understand pharmaceutical production, testing, and quality management; familiar with GMP regulations.
Proficient in English or Mandarin, proficient in both Mandarin and English are preferred, to communicate with team from China and overseas for technical transfer.
Good computer skills.
At least one year experience of GMP Lab related work.
Familiar with the management of analytical laboratories within the industry;
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.
