• Purchasing
• China - Shanghai

 

Our client is a global Pharma & Fine Chemicals Group.

For this client, Talent Fishers is seeking for a QA Audit Specialist. The role takes charge of end-to-end supplier quality audits and onsite factory visits covering regulatory starting materials, GMP intermediates, APIs, excipients and packaging raw materials.

 

Reporting to: Quality & Audit Compliance Manager

 

Location: Shanghai, China

 

 

 

1. Lead onsite quality audits including supplier due diligence, initial & periodic qualification, for-cause and follow-up audits.
2. Own the full audit workflow: audit preparation, onsite execution, report release, CAPA review and closure evidence follow-up.
3. Track supplier compliance status, including official inspection results, GMP non-compliance, regulatory updates and export restrictions.
4. Partner with Procurement, QA and relevant internal teams to advance supplier development and quality system deployment.
5. Ensure full alignment with global regulatory rules, industry quality standards and internal governance policies.
6. Regularly communicate audit findings, potential quality risks and corrective action plans with cross-functional stakeholders.
7. Support and participate in internal, customer-side and regulatory authority audits & inspections.
8. Assist in supplier qualification activities including onsite verification, risk gap assessment, complaint investigation and CAPA implementation.

 

Internal Cross-Functional Collaboration

 

1. Maintain close communication and alignment with internal teams including R&D, Production, Sourcing and Finance, to align on quality standards, material specifications, audit arrangements and compliance requirements.
2. Actively collaborate with cross-functional stakeholders to resolve quality non-conformities, supplier compliance risks and audit-related issues in a timely manner.
3. Share industry regulatory updates, supplier quality performance and audit findings internally; drive cross-department alignment on quality risk mitigation and continuous quality improvement.

 

 

 

1. Bachelor degree in Bio Sentific, Chemistry, Pharmaceutical Engineering or related science majors; Master in Organic Chemistry is preferred.
2. 5+ years solid experience in pharmaceutical/chemical QA or consulting background; prior Lead Auditor experience is an advantage.
3. In-depth command of GMP audit methodology and QA routines: change control, deviation handling, process validation etc.
4. Well-versed in EU GMP, ICH Quality Guidelines and 21 CFR Part 210/211.
5. Holder of UNI EN 19011 or equivalent auditor training certificate.
6. Outstanding interpersonal skills, capable of building stable working relationships with all-level stakeholders.
7. Business fluent in English (written & verbal).
8. Result-driven, strong sense of responsibility, able to work under pressure and meet tight project schedules.
9. Meticulous logical thinking, strong attention to detail and professional document management ability.
10. Familiar with international pharma regulatory norms and professional procurement operation practices.
11. Proficient in Office software and common quality & procurement management systems.

 

 

 

If you are interested in and qualified for this position, please feel free to get in touch via sarah.zhang@talent-fishers.com and share your resume for  the “QA” job application.

Suitable candidates will be contacted within one month upon application.

• Facebook
• Weibo
• LinkedIn
• Email