5 дней назад
Specialist Quality System (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
Specialist Quality System (Biotech): Maintaining and improving quality management systems for a large-scale API biomanufacturing facility with an accent on eDMS, eQMS, documentation, training, deviation, and change control. Focus on supporting GMP compliance, preparing quality metrics and regulatory inspections, and driving continuous improvement across site quality processes.
Location: Yverdon-les-Bains, Switzerland
Company
operates a large-scale API biomanufacturing facility supported by quality assurance and regulated quality management systems.
What you will do
- Support the maintenance and continuous improvement of site quality management systems in accordance with cGMP and Swiss, EU, and US FDA regulations.
- Act as an administrator and subject matter expert for eDMS and eQMS processes, including documentation, retention, training, deviations, and change control.
- Train users, support daily quality-system activities, troubleshoot system issues, and escalate unresolved topics to the Global QMS team.
- Manage documentation change control, controlled copies, local training matrices, GMP filing, archiving, and employee onboarding and termination records.
- Prepare dashboards, KPI extracts, and quality metrics; participate in audits, inspection preparation, and regulatory inspection activities.
- Act as a QA approver or SME for changes, deviations, CAPA, and quality-system improvement projects.
Requirements
- Must speak, read, and write both English and French.
- At least two years of experience in a GMP environment, including the use of electronic systems, preferably in biotechnology, pharmaceuticals, or a related industry.
- Knowledge of quality-system software; experience with Veeva is an advantage.
- Good understanding of GMP requirements and quality systems in the biopharmaceutical industry.
- Bachelor’s degree in pharmacy, chemistry, biology, bio-engineering, bioprocessing, or a related field is an advantage.
- Strong written and verbal communication, pragmatic compliant decision-making, and a results-oriented approach.
Nice to have
- Experience with health-authority inspections.
- Trainer and/or auditor certification.
Culture & Benefits
- Work within a quality assurance team supporting site readiness for Swissmedic and international regulatory inspections.
- Contribute to a culture of business integrity, ethics, compliance, and continuous improvement.
- Collaborate with Bioplant departments and the Global QMS team.
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