7 дней назад
Manufacturing Compliance Coordinator (Biotechnology)
41 250 - 57 750€
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manufacturing Compliance Coordinator (Biotechnology): Supporting GMP readiness and the manufacture of advanced therapy medicines with an accent on quality event investigations, GMP documentation, and cross-functional compliance. Focus on managing deviations, change controls and CAPAs, supporting audits, and driving continuous improvement in a site-based manufacturing environment.
Location: Geleen, Netherlands; fully site-based
Salary: EUR 41,250–57,750 annual base pay
Company
manufactures medicines and supports life sciences innovation through globally connected manufacturing sites.
What you will do
- Support readiness for routine GMP and pre-approval inspections.
- Initiate, review and revise batch records, SOPs, protocols, work instructions and other GMP documentation.
- Investigate and manage deviations, change controls, CAPAs and other quality events through timely closure.
- Collaborate with Manufacturing, Quality Assurance, Production Operators, Biotech Associates and other stakeholders to resolve quality issues.
- Identify manufacturing delivery risks, escalate issues and develop practical solutions within established procedures.
- Support audits, training and continuous improvement while providing cover for the Manufacturing Compliance Lead.
Requirements
- Bachelor’s degree or equivalent in Biotechnology, Life Sciences or a related field.
- Up to four years of relevant experience in manufacturing, pharmaceutical or biotechnology environments.
- Understanding of current Good Manufacturing Practice, preferably in advanced therapy medicinal products or another highly regulated environment.
- Strong planning, prioritisation, problem-solving, communication and relationship-building skills.
- Strong written and verbal English communication skills.
- Proactive, collaborative, detail-oriented approach with a commitment to quality and safety.
Culture & Benefits
- Agile career development and a dynamic working culture.
- Inclusive and ethical workplace.
- Performance-based compensation programs.
- Benefits vary by role and location.
- In-person collaboration within the manufacturing site.
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