Scientist, QC Project Management

Responsibilities:

• Perform method verification, validation and transfer as per procedure.
• Perform Lab tests, calculations and necessary reviewing of Lab records.
• Timely report the identified errors in analytical records to ensure GMP compliance.
• Initiate the related change controls and ensure execution of actions.
• Follow manufacturing progress, ensure availability of reference standards, chromatographic columns and all the test necessaries before the start of manufacturing.
• Involve in the procedure update and ensure procedure execution.
• Communicate with TO and QC project management team. Ensure smoothness of the tests.
• Involve in the Lab management, maintain good working environment, ensure 5S and EHS requirements, ensure Lab safety and the safety of Lab staff.
• 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

Qualifications:

• Pharmacy or Chemistry related major, bachelor's degree or above.
• Understand pharmaceutical production, testing, and quality management; familiar with GMP regulations
• Proficient in English and Chinese, fluent in spoken English and Chinese
• Good computer skills.
• Minimum 5 years Lab experience and project management experience.
• 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 method 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.
• Project management and tracking skills