科创中国

需求描述

职位描述：

1. Set up and recruit the team
2. Maintain and update procedures for supplier qualification, routine performance monitoring, and de-activation.
3. Maintain and update procedures and templates related to supplier audit process.
4. Develop annual supplier audit plan
5. Carry out qualification and routine audit towards STA suppliers for API, excipients, primary and secondary packaging materials, GMP critical consumables, and GMP service provider, etc.
6. Escalate high risk deficiencies identified in supplier audit. in a timely manner, and work across the relevant functions to ensure risk are mitigated
7. Maintain and update list of approved suppliers.
8. Maintain the supplier folders
9. Main the material coding system and regularly update the site material code register.
10. Set-up the auditor pool, to ensure SMEs for various expertise are available, audit reference standards include but not limit to:
a. China Good Manufacturing Practices for Pharmaceutical products, including Annex1 Sterile Products
b. FDA 21 CFR Part 211, including Sterile drug products produced by aseptic processing guidance
c. EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines, including Annex1 Manufacture of Sterile Medicinal Products
d. PIC/S GMP, including Manufacture of sterile medicinal products
e. International Conference on Harmonization (ICH) Documents Q1-11
f. STA QMS
g. ISO 9001
11. Lead or participate the site annual inspection

任职资格：

1. Major in pharmacy or chemistry, bachelor degree or above.
2. Familiar with pharmaceutical manufacturing, testing and quality management, familiar with GMP related regulations;
3. Have a good understanding of pharmaceutical GMP compliance principles and practices;
Good written/oral communication skills in Mandarin/English

办公地址

中国上海外高桥自贸区富特中路288号

处理进度