The CompanyThis company, located in the Amsterdam, is leading in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. In this position you will be joining a newly formed team in which people of all backgrounds and experiences are respected. While working together with a focus on saving lives by finding a cure for cancer.
As a GMP Documentation Specialist you will be responsible for preparing the batch specific document package for manufacturing operations and as well as issuance of other controlled documents.
- Responsible for the management of all document issuance and archival processes to support GMP operations.
- Issue effective documents including procedures, test methods, specifications and batch documentation.
- Ensure accuracy and completeness of QA issued documents.
- Identify and escalate compliance gaps across the document management system
- Execute strategic initiatives to improve the document management system.
- Investigate deviations against the document management system and develop effective corrective action plans.
- Provide training to new staff on document management processes and procedures.
- Support audits (internal, external)
- Support projects as needed
Requirements- BSc/MSc within the Life Sciences
- 2-4 years of working experience in a similar position (Pharma)
- Quality systems experience