7 часов назад
M&S-QA Ops & Batch Release Lead-Shenzhen (Pharmaceutical)
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
M&S-QA Ops & Batch Release Lead-Shenzhen (Pharmaceutical): Ensuring GMP-compliant quality operations and batch release for influenza vaccine manufacturing and imported vaccine packaging with an accent on production audits, quality incident investigations, and regulatory compliance. Focus on approving batch disposition, resolving deviations, implementing risk mitigation and corrective actions, and coordinating quality activities on the shopfloor.
Location: Onsite in Shenzhen, China; the role is highly recommended to be located on the shopfloor.
Company
is a global biopharmaceutical company whose Shenzhen site manufactures influenza vaccines end to end and locally packages imported vaccines for the Chinese market.
What you will do
- Ensure quality operations comply with applicable regulatory requirements, GMP, and internal standards.
- Conduct production-process audits, manage quality issues, lead root cause investigations, and implement corrective and preventive actions.
- Oversee batch release, batch-record review and approval, batch disposition documentation, and release updates in digital tools.
- Perform risk assessments, evaluate deviations including product temperature excursions, and decide on lot disposition.
- Coordinate release activities across Quality Control, production, and Regulatory Affairs to ensure timely batch release.
- Monitor quality and batch-release metrics, support audits and inspections, and promote continuous improvement and a quality-focused culture.
Requirements
- At least 2 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 written and verbal communication skills for effective interaction with colleagues and regulatory bodies.
- Local language and English required.
Culture & Benefits
- Work within a quality operations and PCU team supporting manufacturing and operational excellence.
- Collaborate with production, Quality Control, Regulatory Affairs, and global communities of practice.
- Operate in an environment focused on integrity, patient impact, calculated risks, collaboration, and continuous improvement.
- Equal-opportunity workplace with a stated commitment to diversity, equity, and inclusion.
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