GMP Quality Systems Expert
For one of our clients that operates at the forefront of cancer immunotherapies, we are looking for a Quality System Document Control Specialist. You will take care of the system that handles and stores all the GMP-documentation within the organization and will also be involved in training. Are you an organized and independent professional, with experience in a GMP environment? Read on and apply!
Job description
This international, high-tech biopharmaceutical company produces an innovative cancer immunotherapy and is looking for a Quality System Document Control Specialist. As QS Document Controller, you are responsible for the correct execution, maintenance and enhancements of the records management and document change control systems. Next to this, you execute document management system activities such as the review of documents for completeness and proper authorization. You also make sure the controlled documents are periodically reviewed to make sure that they remain relevant and that the company activities are reflected as described in applicable procedures. Various QA tasks, such as deviation investigations, developing corrective action plans, and supporting of audits as document SME, are also part of your activities. You also provide new staff with training on document management procedures and support other QA training activities when needed.Responsibilities
- Execution, maintenance, and enhancement of the record management and document change control systems, including storage, retrieval, retention, and destruction,
- Perform document management system activities
- Periodic review of controlled documents to ensure relevance and company activities to comply to applicable procedures
- Identify and escalate compliance issues in the document management system
- Investigate deviations and develop corrective action plans
- Provide new staff with training on document management processes and procedures
- Support, both internal and external, audits as document management SME
Profile
- Finished HBO or WO education in a relevant field (e.g. (Bio)medical, Pharmaceutical and/or Life Sciences)
- At least 2 years of experience in a QA position, preferably in documentation management, under GMP regulations is a must
- Strong in communication in a clear and concise way in English
- Being able to prioritize and plan and follow up with and for your team
Benefits
- Start with an Oxford contract, short term position with the possibility for extension
- Salary range: €3800 - €4500, depending on experience
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