Job description:

If you have an eye for detail and want to help assure quality and facility qualifying and monitoring supply chain’s via audits in the animal health, pharmaceutical and similar regulated environments space, then this is the role for you! We have upcoming projects in China in 2025, 2026 and beyond!

We're looking for an auditor in China to perform audits within China. It’s preferable that you be relatively close to airport/high speed train options that will take you quickly to locations throughout China.

We're looking for a Sr. Quality Auditor with the following knowledge and experience:

•Language: Ability to conduct a Chinese, to speak and read English, and the ability to write a report in English. 

•Technical Qualifications:

6

At least five years’ experience in quality role and/or as auditor

Experience performing audits as a lead auditor

Experience as lead auditor and/or in a quality role where you have been responsible for ensuring animal drug manufacturers’ compliance to good manufacturing practices (GMPs) and pharmaceutical drug products

Experience as lead auditor and/or in a quality role where you have been responsible for ensuring compliance to Chinese Veterinary GMPs 2020, Eudralex Vol 4, Good Manufacturing Practice, Medical Products for Human and Veterinary Use, PIC/S GMP, and 21 CFR part 210/211

Experience as lead auditor and/or in a quality role where you have been responsible for ensuring active pharmaceutical ingredient (API) manufacturers’ compliance to good manufacturing practices (GMPs), including ICH Q7 and Eudralex Vol 4 Volume II: Basic Requirements for Active Substances used as Starting Materials

Experience as lead auditor and/or in a quality role where you have been responsible for ensuring primary packaging production site’s and secondary packaging site’s compliance to good manufacturing practices (GMPs)  requirements

Experience as lead auditor and/or in a quality role where you have been responsible for ensuring warehousing and distribution site’s compliance to good distribution practices (GDPs)

Preferred to have experience as lead auditor and/or in a quality role where you have been responsible for ensuring compliance to good distribution practices of animal health products (e.g. animal drugs, food, feed, other)

Preferred to have experience as lead auditor and/or in a quality role where you have been responsible for ensuring compliance to ICH Q9 and Q10 and WHO (Word Health Organization Guidelines) GMP and 21 CFR part 11

What you’ll do:

You will be performing quality audits and writing reports, either internally, or at suppliers to SQA’s clients. Each client has unique program needs to which you will be oriented as part of your on-boarding for each program. SQA will provide the audit tools and templates you'll need to conduct the audit effectively and seamlessly in accordance with SQA's and our client's requirements.

What to expect:

You will be part of a global quality auditing team responsible for assuring quality in the supply chains of our clients in life sciences, including animal health. Covering your local region, you will work closely with SQA’s operations center to coordinate, prepare, execute, and deliver supplier quality audits based on client audit schedules. You will work with SQA’s world-class production team to align your expert findings to the individual structure and guidelines of each client’s managed audit program.

$1,200 - $1,400 a day

SQA is an Equal Opportunity Employer.  Employment is based  on merit and qualifications and is not influenced by race,  color,  religion,  gender,  national  origin,  veteran  status,  disability, age,  sexual orientation, gender identity, marital status, or any other legally protected status.

 

This position requires access to ITAR-controlled technical data and/or defense articles. As such, the candidate must be a U.S. citizen or U.S. lawful permanent resident (green card holder) to comply with the International Traffic in Arms Regulations (ITAR). Applicants who do not meet these criteria will not be considered for this role.

#ZR