25 дней назад
QA Sterility Assurance Lead (SAL) - Drug Product 80-100% (f/m/d) (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
QA Sterility Assurance Lead (SAL) - Drug Product 80-100% (f/m/d) (Pharmaceutical): Leading the Sterility Assurance and Microbial Control Program for a drug product module in Visp with an accent on contamination control, aseptic processing, environmental monitoring, and regulatory compliance. Focus on owning the Contamination Control Strategy, leading complex microbiological investigations, and strengthening sterility assurance across operations, engineering, quality, and technical functions.
Location: Visp, Switzerland; relocation assistance is available for eligible candidates and their families
Company
operates globally connected life-science manufacturing sites that develop and manufacture medicines.
What you will do
- Own and continuously improve the Contamination Control Strategy in line with regulatory requirements, company guidelines, and industry best practices.
- Provide technical leadership for aseptic processing, aseptic process simulations, sterilization, cleanroom management, and contamination control programs.
- Act as the Sterility Assurance Subject Matter Expert for facility design, technology transfers, and contamination risk assessments.
- Lead investigations, corrective and preventive actions, and root cause analyses related to sterility assurance.
- Manage environmental monitoring strategies, performance metrics, trend analysis, and continuous improvement initiatives.
- Represent Sterility Assurance during health authority inspections, customer audits, and cross-functional activities.
Requirements
- Academic degree in a scientific discipline with extensive pharmaceutical-industry experience in microbial control and sterility assurance.
- Hands-on expertise in contamination control, aseptic processing, aseptic process simulations, environmental monitoring, and complex microbiological investigations.
- Knowledge of cleanroom engineering, sterilization processes, microbiological testing methodologies, and contamination risk management.
- Understanding of pharmaceutical regulations and GMP requirements, including USP/EP, bioburden, endotoxin, sterility testing, and contamination control systems.
- Strong communication, decision-making, conflict-resolution, and change-management skills.
- Business-fluent English is required.
Nice to have
- German language skills.
Culture & Benefits
- Agile career environment and dynamic working culture.
- Inclusive and ethical workplace with a focus on diversity.
- Performance-oriented compensation programs.
- Benefits vary according to role and location.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →