You will be responsible for organizing to define quality system, guide and supervise the implementation, to ensure company complies with applicable RD Quality Standards and local regulatory requirements and ensuring the regulatory and Company SOP compliance in QA system and business activities.

• Leading team to be responsible for quality system maintenance, training and company business license maintenance to ensure in compliance with RD quality standards and local regulations.
• Leading team to coordinate with relevant departments on regulatory and quality controlling, new product and supplier control, establish and maintain product file and categories, product registration certification information check, Chinese labeling and PI quality control (including RUO/IUO labeling), product promotion material check, guide on GxP related content in computer system to ensure compliance with RD quality standards and local regulations.
• Leading team to responsible for guide and supervise on 3PL processes like incoming goods reception, in stock goods maintenance, return , transportation etc. , coordinate to monitor and assess 3PL quality assurance capabilities, to ensure in compliance with RD quality standards and local regulations.
• Quality Documents & Records Control and Change Control. Keeps records. Has clear filing and maintain of all documents.
• Coordinating and supporting for External Audit, Internal Audit.

You should hold:

• Bachelor degree or above, subject on clinical laboratory Medicine/Medical/bioengineering/ biochemistry; licensed pharmacist or clinical laboratory technician-in-charge preferred.

You should have:

• Above 5years’ QA experience, especially in QA management, GSP and ISO 13485 certification.
• Proficiency in both spoken and written English.