- 経験
- 3年以上
- 給料
- —
- 求人情報
- 1
- 投稿済み
- 6時間前
- 作業モード
- 在任中
- 教育
- Bachelor's degree in Pharmacy, Chemistry, or a related field
- 資格
- Candidates with a pharmacy or chemistry background who have laboratory experience, GMP data review exposure, and fluency in English and Chinese are eligible to apply.
- 再開する
- 応募必須
勤務地
仕事内容
Role overview
WuXi AppTec is looking for a Quality Control Data Reviewer to support laboratory quality operations in Tuas, Singapore. The role focuses on checking analytical records, confirming data integrity, and helping maintain GMP-compliant lab practices.
Key responsibilities
- Use chromatographic systems such as Waters Empower 3 and Agilent CDS 2 to support review activities.
- Review analytical methods, test plans, experimental records, calculations, and data integrity in line with the applicable SOPs.
- Identify mistakes or gaps in analytical documentation and report them promptly to support GMP compliance.
- Handle lab events, OOX cases, and deviations, and participate in investigations when required.
- Contribute to procedure revisions and help ensure updated procedures are properly followed.
- Support lab administration by maintaining a clean, well-controlled, safe, and 5S-compliant working environment.
- Apply knowledge of regulatory references such as BP, USP, JP, and EP when updating internal procedures.
- Support customer and government audit activities, complete corrective actions on time, and help keep the site GMP-ready.
- Take on other duties assigned from time to time.
- Assist department leadership in developing an efficient and high-performing team.
Requirements
- A bachelor's degree or higher in Pharmacy, Chemistry, or a related field.
- Good understanding of pharmaceutical manufacturing, testing, and quality systems, with familiarity in GMP requirements.
- Strong command of both English and Chinese, including spoken fluency for communication with internal and external stakeholders in China and overseas.
- At least 3 years of laboratory-related experience, including more than 1 year in GMP data review or a closely related role.
- Knowledge of technical standards for analytical operations and the documentation requirements for analytical methods.
- Understanding of data integrity expectations for analytical software used in the industry.
- Ability to manage on-site issues effectively, with solid coordination, communication, and execution skills.
- Careful, proactive, and capable of working well under pressure.
- Strong analytical thinking, including the ability to identify issues, collect relevant information, interpret facts, and reach sound conclusions.
Work environment
This is a full-time, on-site position based in Tuas, West Region, Singapore.