3 часа назад
Specialist Quality Assurance (Biopharmaceutical Manufacturing)
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
Specialist Quality Assurance (Biopharmaceutical Manufacturing): Managing deviation and CAPA quality management systems at a Singapore manufacturing site with an accent on process governance, inspection readiness, and quality documentation. Focus on leading system updates, representing site processes during audits and regulatory inspections, and driving corrective actions and process improvements.
Location: Singapore Manufacturing - Tuas
Company
develops biological medicines and applies scientific and technological expertise to address serious diseases and improve patient outcomes.
What you will do
- Manage assigned Quality Management Systems, including deviations and CAPA, as the site subject matter expert and network representative.
- Implement process changes, monitor execution, assess performance, and communicate impacts to global process owners, users, and management.
- Lead site projects for quality system updates and rollouts, and contribute to site, functional, and regional process improvement initiatives.
- Review global standards and author quality documentation, procedures, and training materials where required.
- Onboard, train, coach, and mentor users while escalating quality performance issues and trends.
- Maintain inspection readiness and represent quality processes during audits and regulatory agency inspections.
Requirements
- Doctorate degree, or a master's degree with 2 years of directly related experience, bachelor's degree with 4 years of directly related experience, or diploma with 8 years of directly related experience.
- At least 8 years of related experience in pharmaceutical or biologics manufacturing, process development, or quality assurance.
- Demonstrated experience in project management, quality assurance, and quality systems with progressively increasing responsibility.
- Experience with regulatory audits and inspections, technical writing, presentations, and collaboration with technical and senior management staff.
- Strong problem-solving skills and the ability to assess data and make decisions related to compliance and product quality.
- Medical requirements for the job scope must be fulfilled; required medical checks are paid for by the company.
Nice to have
- Direct experience with bulk manufacturing of biopharmaceuticals or APIs.
Culture & Benefits
- Collaborative environment focused on continuous learning and meaningful work.
- Competitive benefits and professional development opportunities.
- Inclusive workplace built around diverse, ethical, and accomplished employees.
- Reasonable accommodations are available for qualified individuals with disabilities.
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