14 дней назад
Quality Assurance Specialist (Biotech)
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
Quality Assurance Specialist (Biotech): Providing QA oversight for commissioning, qualification, validation, technology transfer, process lifecycle management, and capital projects with an accent on GMP documentation, regulatory compliance, and risk-based decision-making. Focus on reviewing validation and qualification records, supporting deviations and CAPA, and coordinating quality activities across engineering, manufacturing, regulatory, and supply chain teams.
Location: Brisbane, Australia
Company
operates in the biotechnology and regulated life science sector.
What you will do
- Provide Quality Assurance oversight for engineering, validation, manufacturing, and capital project activities.
- Review and approve GMP documentation, including validation protocols, qualification documents, risk assessments, technology transfer records, and quality system records.
- Support commissioning, qualification, validation, technology transfer, and process lifecycle management.
- Facilitate deviations, investigations, change controls, CAPA, and risk management activities.
- Provide quality guidance and risk-based decisions to project teams and operational stakeholders.
- Collaborate with Engineering, Manufacturing, Validation, Quality Control, Supply Chain, and Regulatory teams, while supporting audits and vendor qualification.
Requirements
- Bachelor’s degree in Engineering or Life Science.
- At least 2 years of experience in Quality Assurance, Validation, Manufacturing Quality, or Project Quality within pharmaceutical, biotechnology, medical device, or other regulated industries.
- Experience reviewing and approving GMP documentation, including risk assessments, validation protocols, qualification documents, change controls, deviations, and CAPAs.
- Experience supporting technology transfer, process validation, qualification, engineering, manufacturing, or capital projects.
- Working knowledge of cGMP, GxP, FDA, EMA, TGA, PIC/S, and international regulatory requirements.
- Strong technical writing, document review, and cross-functional stakeholder relationship skills.
Culture & Benefits
- Six-month contract engagement.
- Work involves collaboration across multiple technical and operational functions.
- Responsibilities support quality, compliance, and continuous improvement throughout the project lifecycle.
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 →