Operations Management, QC Specialist

WuXi AppTec Singapore Pte. Ltd.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A prominent biopharmaceutical company is seeking a Lab Management Professional in Singapore. This role involves overseeing samples, reference standards, and reagents while ensuring compliance with GMP. Candidates must communicate fluently in English and Chinese to support technical transfers and participate actively in audits and inspections. The ideal candidate will have a strong understanding of lab procedures and regulatory documents. The position involves a range of responsibilities, including timely reporting of lab issues and adapting to changing procedures within the lab context.

Qualifications

• Proficient in English and Chinese, with strong verbal skills in both languages.
• Ability to manage samples and references in a lab environment.
• Experience with regulatory documents and GMP compliance.

Responsibilities

• Manage samples, reference standards, and reagents.
• Ensure lab compliance with GMP standards.
• Participate in audits and inspections.
• Document lab events and issues.

Job description

Responsibilities

• 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.
• Proficient in English and Chinese, fluent in spoken English and Chinese to liaise with stakeholders from China and overseas, to support technical transfer
• Perform any other ad hoc duties as required by the Department