12 дней назад
MS QA Specialist (Pharmaceutical)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
MS QA Specialist (Pharmaceutical): Ensuring pharmaceutical manufacturing, distribution, and marketing activities in China comply with GMP, GDP, Sanofi quality standards, and regulatory requirements with an accent on audits, batch documentation, deviation management, and CAPA. Focus on leading root cause investigations, managing CMO inspections, reviewing product quality records, and implementing risk-based corrective and preventive actions.
Location: Beijing, China; onsite work with strong expectation to be located on the shopfloor
Company
operates global manufacturing platforms and supporting quality, supply, and lean strategy functions focused on producing and delivering high-quality medicines.
What you will do
- Ensure distribution, marketing, manufacturing, and other in-scope activities comply with quality policies, GMP, GDP, and applicable Chinese regulations.
- Manage quality processes, conduct production-process audits, and monitor quality performance metrics.
- Investigate deviations, complaints, and quality incidents; lead root cause analysis and support CAPA implementation and effectiveness checks.
- Review batch records, batch disposition documentation, product quality reviews, and quality-related procedures and SOPs.
- Participate in internal and external audits, regulatory inspections, and on-site CMO inspections.
- Advise on risk management, corrective actions, digital transformation initiatives, and quality culture improvements.
Requirements
- At least 3 years of quality assurance experience in the pharmaceutical industry.
- Strong knowledge of GMP and quality assurance principles.
- Ability to analyze complex data, identify trends and issues, and implement effective corrective actions.
- High accuracy and attention to detail, with the ability to manage multiple projects and meet quality standards.
- Strong verbal and written communication skills for interaction with colleagues and regulatory bodies.
- Chinese and English language skills required.
Culture & Benefits
- Work within a quality-focused pharmaceutical manufacturing and supply organization.
- Support global standards alongside local Chinese regulatory requirements.
- Contribute to continuous improvement, digital transformation, and quality culture initiatives.
- Follow company health, safety, and environment policies and procedures.
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