Quality Auditor, China

Actylis is a leading manufacturer and supplier of critical raw materials and performance ingredients serving the Life Sciences, Specialty Chemicals, and Agriscience industries.

We offer standard and custom ingredients through our rapidly growing portfolio of GMP and non-GMP facilities worldwide, and further choice through our strong sourcing hub network. This unique hybrid option blending manufacturing and global sourcing, combined with more than 75 years of sourcing and distribution experience makes Actylis the Partner of Choice.

LOCATION:               Actylis Shanghai

POSITION SUMMARY:
The Global Quality Auditor will be responsible for conducting thorough audits of manufacturing sites, research and development centers, contract organizations, and/or vendors across China to ensure compliance with regulatory standards, internal policies, and Good Manufacturing Practices (GMP). The Global Auditor will play a key role in supporting risk management, ensuring operational excellence, and maintaining compliance across our global supply chain.

Key Responsibilities:
•    Conduct Global Audits:
o    Plan, schedule, and execute audits of suppliers and/or contractors to ensure compliance with global regulations (GMP, GLP, GDP, ISO, APIC, ICH Q7) as per product compliance requirements.
o    Accompany Customer Audits of Actylis suppliers and ensure a smooth and successful auditing process.
o    Review Customer Audit Agendas to ensure the scope is commensurate with the Supplier’s QMS and the product compliance level required.
o    Perform risk-based audits, focusing on critical areas such as product quality, data integrity, and operational compliance, as required.
o    Plan, schedule, and execute internal audits of Actylis distribution and/or manufacturing sites with regards to Corporate Policies to ensure compliance.
•    Regulatory Compliance:
o    Ensure adherence to international regulatory standards, including those of the FDA, EMA, WHO, ICH, ISO and/or other relevant regulatory or certification bodies. 
o    Stay updated on changes in pharmaceutical/ISO regulations and industry best practices to ensure continuous compliance.
o    Prepare audit reports and corrective action plans (CAPA) based on findings to mitigate risks and address non-conformities.
•    Stakeholder Collaboration:
o    Collaborate with cross-functional teams including quality assurance, regulatory affairs, and supply chain to ensure audit outcomes are integrated into continuous improvement strategies.
o    Work with external partners, including contract manufacturing organizations (CMOs) and third-party vendors, to ensure they meet compliance standards.
o    Provide recommendations for process improvements and remediation activities in response to audit findings.
•    Risk Assessment & Management:
o    Conduct risk assessments to identify high-risk areas within the company’s global operations.
o    Participate in the development of annual audit plans, prioritizing audits based on identified risks and regulatory requirements.
•    Documentation & Reporting:
o    Document and communicate audit findings clearly and concisely to senior management.
o    Ensure follow-up on the implementation of corrective actions and preventative measures.
o    Maintain thorough and accurate records of all audits, including any compliance violations or quality issues.

Qualifications & Experience:
o    Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or a related field. 
o    Certified Internal Auditor (CIA) or Certified Quality Auditor (CQA), highly desired.
o    Minimum 3 years of experience in auditing within the pharmaceutical industry, with a focus on GMP compliance, regulatory affairs, or quality assurance.
o    Thorough understanding of global regulatory requirements (FDA, EMA, ICH, WHO, ISO 9001:2015 etc.) and good knowledge of industry best practices.
o    Ability to travel up to 60% of the time, as audits are performed across China.
o    Experience in a manufacturing setting is considered a strong asset.

Key Skills:
•    Strong knowledge of GMP, GLP, ICH, ISO 9001:2015 and other pharmaceutical industry standards.
•    Excellent analytical and problem-solving skills with attention to detail.
•    Strong communication skills for clear reporting and ability to influence and negotiate with stakeholders.
•    Familiarity with risk assessment methodologies and audit planning.
•    Proficient in audit tools, systems, and methodologies.
•    Ability to manage multiple audits and meet deadlines in a fast-paced environment.

SUPERVISORY RESPONSIBILITIES: N/A

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.  The employee is occasionally required to stand, walk, and climb or balance. The employee must occasionally lift and/or move up to 10 pounds.  Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level in the work environment is usually moderate.

The above statements are intended to describe the general nature and level of work being performed by persons assigned to this position. They are not intended to be an exhaustive list of all associated tasks and responsibilities.

Actylis is an Equal Opportunity Employer. Actylis does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need.