Key Responsibilities:

Serve as lead auditor to perform comprehensive on-site GMP compliance audits for API, finished dosage form, and related manufacturing sites.

Audit scope includes quality systems, production, laboratory operations, facilities & equipment, materials management, and data integrity.

Accurately identify non-conformances and potential compliance risks.

Prepare professional, clear, and objective audit reports in English, documenting findings and conducting risk assessments.

Track and evaluate the appropriateness and effectiveness of clients’ corrective and preventive action (CAPA) plans.

Maintain effective communication with the audit operations team and other collaborating departments.

Participate in internal auditor training programs and contribute to the update and maintenance of the knowledge base.

Qualifications and Requirements :

Bachelor’s degree or higher in Pharmacy, Pharmaceutical Engineering, Chemistry, Biology,Microbiology, or a related field.

8+ years of compliance-related experience in the pharmaceutical or biopharmaceutical industry, including at least 2 years leading GMP audits.

Proficient in international GMP regulations (e.g., China GMP, EU GMP, FDA 21 CFR Part 210/211, ICH Q7/Q8/Q9/Q10) and their core requirements.

Familiar with the drug lifecycle and well-versed in quality management systems, risk management, deviation management, data integrity, validation, and qualification.

Keen insight and judgment to quickly identify key compliance risks.

High integrity and objectivity, maintaining an independent and impartial auditing stance.Strong communication skills to interact effectively with audit stakeholders.

English proficiency: able to read regulatory documents, write audit reports, and conduct work-related communication in English.

Adaptability to frequent domestic travel.

Advantageous:

In-depth auditing experience in specialized areas such as sterile products, biologics, cell and gene therapy, etc.

Experience in Good Distribution Practice (GDP) auditing is a plus.

Job Description:

As a core member of the consulting team, you will provide professional GMP (Good Manufacturing Practice) compliance consulting services to domestic and international pharmaceutical and related enterprises, helping clients address regulatory challenges and establish or improve their quality management systems.

Key Responsibilities:

Conduct GMP compliance gap analysis, risk assessment, and design corrective action plans for clients.

Assist clients in establishing, optimizing, and maintaining quality management documentation (e.g., Quality Manual, SOPs, Validation Master Plans) compliant with international GMP requirements (such as China NMPA, US FDA, EU EMA).

Provide on-site support and mock audit services during critical stages such as GMP compliance inspections and client audits.

Offer technical compliance guidance in specific areas such as APIs, finished dosage forms, and biologics.

Conduct supplier audits.

Plan, execute, monitor, and deliver consulting projects independently or collaboratively, ensuring timely and high-quality completion.

Prepare professional consulting reports, assessment documents, and project summaries.

3. Client Relationship & Business Development:

Build and maintain long-term, trusted professional relationships with clients, gaining deep insight into their needs.

Identify new business opportunities and participate in pre-sales technical support.

4. Knowledge Contribution & Training:

Contribute to internal knowledge base development by sharing industry insights and best practices.

Design and deliver GMP-related training programs for clients or internal teams.

Background & Requirements

Experience as a core quality personnel, leading or deeply participating in successful domestic or international GMP inspections (e.g., NMPA, FDA, EMA) or major client audits.
3. Professional Knowledge:
Proficient in international GMP systems (e.g., China GMP, EU GMP, FDA 21 CFR Part 210/211, ICH Q7, Q9, Q10).

Deep understanding and practical experience in key quality system elements across the product lifecycle (e.g., deviation investigation, OOS, change control, CAPA, validation & qualification, supplier management, data integrity).

Strong analytical and problem-solving skills: Ability to quickly identify compliance gaps and propose practical solutions.

Excellent communication skills: Proficient in both written and spoken English (capable of drafting professional English reports and conducting meetings in English), with the ability to clearly and persuasively convey complex concepts to clients and teams at various levels.

Client-oriented and service-driven: Committed to client success with high professionalism and responsibility.

Adaptability: Willingness to travel as required.