- Key leadership and collaboration with manufacturing partners and sites
- Site qualification activities
- Perform GMP Auditing across a range of stakeholders
- Use continuous improvement methods to enhance the quality system in GMP
- Ensure the QMS is aligned with the corporate/global standard
- Support and lead deviations, CAPA's and other operational aspects in QA
- Overall support to QA group for GMP aspects
- Must be educated within a life science or engineering discipline to at least a BSc or higher
- Have demonstrated experience working in the Pharmaceutical/Biologic industry in Quality Assurance
- Well versed in QA within a GMP setting
- Fluent in English (Dutch would be highly preferred but not essential)
- Can perform the contract to the standards set out in the job description
- Currently based in the Netherlands would be highly preferred
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Freelance Quality Assurance Specialist - Leiden, Nederland - ProPharma Group
Beschrijving
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
Responsibilities included:
Skills required
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***