QA for audit and compliance

Job Responsibilities:

Responsible for managing on-site or remote customer audits, including pre-audit preparation, on-site hosting, follow-up communication, and response to findings.

Participate in GMP regulatory audits (e.g., NMPA, FDA, EMA), ensuring the audit process proceeds smoothly and complies with regulatory requirements.

Develop, coordinate, and execute the company’s annual internal GMP self-inspection plan based on quality risk.

Track the completion of self-inspections across all areas to ensure compliance with internal procedures and domestic and international GMP regulations.

Oversee root cause analysis and CAPA development for all internal and external audit findings and track the closure of actions.

Engage in quality risk management activities, integrating audit findings into the risk management system.

Regularly participate quality meetings with customers to monitor project quality and discuss quality matters

Support other internal teams in making decisions from the customer's perspective

Coordinate support for cross-site QA transactions and issue resolution

Qualifications:

Educational Background:

Bachelor’s degree or above in Pharmacy, Pharmaceutical Engineering, Chemistry, Biology, Microbiology, or related science/engineering fields.

Work Experience:

At least 10 years of experience in QA, QC, or production within the pharmaceutical industry

Candidates with substantial experience in managing domestic and international regulatory audits (e.g., NMPA, FDA) and customer audits are preferred.

Professional Knowledge and Skills:

In-depth understanding and mastery of domestic and international GMP regulations, including China NMPA GMP, US FDA cGMP, EU EudraLex GMP, and other relevant regulatory systems.

Proficient in audit techniques with advanced methodologies to keenly identify deficiencies and risks in quality systems.

Excellent documentation skills with the ability to prepare well-structured and justified audit reports or audit response documents.

Strong computer skills, including proficiency in Microsoft Office and related software.

Language Requirements: excellent English listening, speaking, reading, and writing skills, with exceptional oral communication abilities.