Ensure projects/products developed or sourced to meet applicable compliance and R&D specifications, Success Criteria and global product quality standards, by project quality management and implementing and continually improving Quality Systems, together with cross functional team and suppliers.
- Work with R&D, Global Regulatory and Packaging to minimize or eliminate quality risk in NPD, EPD;
And ensure the compliance from product safety certification, RoHS, REACH;
- Manage the change and transfer without quality negative impact;
- Drive the CPM to a satisfactory level, ensure Suppliers develop and implement effective and timely corrective action;
- Ensure the operation of EAST quality are compliant to the requirements of RB QMS manuals and procedures;
- Arrange and carry out an audit program (ISO9001, ISO13485, GMP, applicable procedures) to EMOs and drive CAPA for the issues affecting product quality;
- Ensure Quality is a key criterion for the selection of Suppliers.
- Bachelor’s degree; major in Chemistry, Life Sciences, Pharmaceutics or other related.
- 1+ years’ experience in manufacturing site is preferred.
SKILLS AND COMPETENCIES/PERSONAL ATTRIBUTES
- Fluency – written and spoken in English and Chinese (preferably both Mandarin and Cantonese)
- Good communication and presentation skills
- Problem solving in shop floor and reporting;
- Decent, self-motivated, open-mind, fast learner.
- Knowledge of relevant regulatory or medical device standards are preferred but not a must
- Experience of working in famous manufacturing companies will be an advantage