10 дней назад
Quality Assurance Specialist (Pharmaceutical)
44 700 - 70 840€
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Quality Assurance Specialist (Pharmaceutical): Ensuring biologics site and supply chain activities meet cGMP standards through investigations, CAPA management, regulatory inspection readiness, and quality approvals with an accent on product quality, compliance, and patient safety. Focus on leading root cause analysis, evaluating change controls and validation protocols, and driving continuous improvement across site operations.
Location: Leiden, South Holland, Netherlands; onsite
Salary: €44,700–€70,840 annual base pay
Company
Johnson & Johnson develops innovative medicine and MedTech solutions, including biologics, to improve patient health and safety.
What you will do
- Provide cGMP and quality advice during routine and non-routine site and supply chain operations.
- Lead site investigations, root cause analysis, and CAPA implementation.
- Prepare for and support FDA, EMA, and other regulatory inspections.
- Review and approve change controls for commercial production and quality control testing.
- Evaluate study and validation protocols and reports.
- Collaborate on quality risk management and continuous improvement initiatives.
Requirements
- Bachelor’s degree in bioscience, chemistry, pharmacy, or a related field with 4–6 years of relevant experience, or a Master’s degree with 2–4 years of relevant experience.
- Experience in Quality Assurance within the pharmaceutical industry or a related field.
- Experience leading quality investigations, root cause analysis, and CAPA management.
- Current knowledge of cGMP and applicable regulatory expectations.
- Fluency in Dutch and English, both written and verbal, is required.
Nice to have
- Familiarity with Process Excellence, LEAN tools, concepts, or similar process improvement methods.
Culture & Benefits
- Inclusive work environment focused on diversity, dignity, and individual contribution.
- Annual bonus based on pay grade, location, and company and employee performance.
- Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
- Well-being reimbursement and financial, physical, and mental health programs.
- Insurance plans and service anniversary and recognition awards, subject to applicable plan terms.
Hiring process
- Application and CV review.
- Short recruitment call for suitable candidates.
- Country-specific checks before starting the role.
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