4 дня назад
Senior QA Compliance Specialist (GMP)
46 500 - 65 100€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior QA Compliance Specialist (GMP): Maintaining and strengthening the site Quality Management System in a GMP-regulated life sciences environment with an accent on quality events, risk management, compliance programs, and inspection readiness. Focus on leading deviation and CAPA reviews, supporting audits and regulatory inspections, and implementing continuous improvements across quality systems.
Location: Geleen, Netherlands
Annual base salary: EUR 46,500–65,100
Company
is a global life sciences organization with more than 30 sites across five continents, manufacturing medicines and supporting customers in developing breakthrough therapies.
What you will do
- Oversee the site's Quality Management System, quality events, quality risk management activities, and compliance programs.
- Lead the Deviation Review Board and review or approve deviations, CAPAs, change requests, investigations, and audit commitments.
- Author, review, and maintain QMS documentation and support the implementation of site and global quality standards.
- Review quality risk assessments and support risk management activities.
- Support internal and external audits, regulatory inspections, and inspection readiness.
- Deliver QMS and compliance training and implement improvements with cross-functional stakeholders.
Requirements
- At least 5 years of experience in quality management, quality systems, or compliance within a GMP-regulated pharmaceutical or biotechnology environment.
- Strong experience with quality events, including deviations, CAPAs, change requests, investigations, and quality risk management.
- Strong knowledge of QMS principles, GMP requirements, risk management, and inspection readiness.
- Experience supporting audits, regulatory inspections, and compliance programs.
- Strong analytical, problem-solving, decision-making, and stakeholder management skills.
- Bachelor's degree or equivalent qualification in a relevant discipline, preferably with life sciences experience.
Nice to have
- Experience in sterile manufacturing.
Culture & Benefits
- Agile career development and a dynamic working culture.
- Inclusive and ethical workplace focused on collaboration, accountability, excellence, passion, and integrity.
- Performance-based compensation programs.
- Cross-functional work and opportunities to contribute to continuous improvement.
- Benefits vary according to role and location.
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