5 дней назад
Quality Assurance Officer (GMP)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Assurance Officer (GMP) (pharmaceutical and medical device microbiology): Ensuring quality across laboratory and operational processes with an accent on GMP compliance, deviation and CAPA management, documentation control, and audits. Focus on implementing regulatory requirements, training personnel, maintaining quality systems, and supporting inspections and continuous improvement projects.
Location: Nijmegen, Netherlands; candidates must be located in the Netherlands within reasonable distance of the site, hold a valid work permit, and be available for 32 hours per week.
Company
Eurofins Bactimm is a microbiological testing laboratory within , serving pharmaceutical and medical device clients with analyses of raw materials and finished products.
What you will do
- Manage deviations, changes, complaints, OOS investigations, and CAPA in accordance with GMP guidelines.
- Maintain change control, deviation, GMP documentation, archiving, and electronic quality systems.
- Perform routine QA activities, create and revise procedures, and support QA agreements.
- Conduct internal audits and self-inspections, and support inspections by regulatory authorities.
- Train personnel on GMP and quality procedures and contribute to QA initiatives and improvement projects.
- Ensure GxP compliance for personnel, validation studies, facilities, and equipment while acting as deputy for the QA Manager.
Requirements
- Bachelor’s degree or higher in biochemistry, chemistry, biotechnology, pharmacy, molecular biology, or a related field, or an MBO degree with at least 3 years of relevant experience.
- At least 1 year of experience in the biopharmaceutical industry and at least 1 year in a GMP, GLP, or ISO quality environment.
- Knowledge of GMP quality systems and regulatory requirements, including EudraLex and ICH.
- Fluency in Dutch or English; knowledge of both languages is preferred.
- Organized, structured, accurate, quality-oriented, proactive, and customer-focused.
- Must be located in the Netherlands, hold a valid work permit, and be available for a 32-hour-per-week contract.
Nice to have
- Knowledge of microbiological quality control testing.
- Fluency in both Dutch and English.
Culture & Benefits
- Collaborative, close-knit team with room for individual ideas and input.
- Flexible working hours and a competitive salary.
- 25 vacation days, with the option to purchase 7 additional days.
- Travel allowance or full public transport reimbursement through an NS Business Card.
- Pension scheme with a 50% employer contribution, health insurance discount, and an 8.95% monthly choice budget.
- Professional training, development opportunities, and access to the Good Habitz online learning platform.
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