12 часов назад
Third Party Quality Auditor (Pharma)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Third Party Quality Auditor (Pharma) (GxP and cGMP): Organizing and performing on-site and remote audits of pharmaceutical and other health-regulated third-party vendors with an accent on supplier quality, regulatory compliance, and CAPA follow-up. Focus on assessing manufacturing and service providers, supporting root cause investigations, managing audit programs, and maintaining inspection readiness.
Location: Chengdu, China; the role includes on-site and remote audits and travel.
Company
is a global healthcare company focused on developing medicines and improving patient outcomes through science.
What you will do
- Plan, organize, and perform quality audits of third-party manufacturers, suppliers, and service providers.
- Assess compliance with material, regulatory, quality, GxP, cGMP, corporate, and country-specific requirements.
- Identify quality gaps, coordinate CAPA follow-up, and facilitate the exchange of quality information between suppliers, sites, and global quality stakeholders.
- Support complex and for-cause audits, auditor qualification, supplier quality investigations, and root cause analysis.
- Lead quality compliance activities, maintain inspection readiness, and manage supplier audit programs.
- Monitor FDA and EMA requirements, regulatory changes, market developments, and quality risk management activities.
Requirements
- Bachelor’s degree in science, pharmacy, biotechnology, microbiology, or a related field.
- At least 7 years of experience in quality or regulatory functions within a pharmaceutical or biopharmaceutical company.
- Experience conducting third-party audits across APIs, excipients, chemicals, raw materials, drug product manufacturers, and service providers.
- Thorough knowledge of cGMP, GMP requirements, the Code of Federal Regulations for drugs and biologics, quality systems, and CAPA.
- Experience with on-site audits, inspections, and regulatory or health authority inspections; readiness to travel.
- Native Chinese and fluent spoken and written English are required.
Nice to have
- Experience managing third-party manufacturers or contract manufacturing organizations.
- Experience working at manufacturing sites.
- GxP auditor certification from a recognized certifying agency.
Culture & Benefits
- Full-time employment within a global healthcare organization.
- Opportunities to collaborate with regional and global quality stakeholders.
- Equal-opportunity workplace supporting people from diverse backgrounds.
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