Max. € 60,000
Detachering via YER
Medical & Health
Over deze vacature
The Documentation Specialist will provide compliant, accurate and timely documentation support. The Documentation Specialist is accountable to ensure the timely generation and approval of all key documents supporting the program schedule.
Primary responsibilities include coordinating and managing approval of key project documents, developing a site system for the tracking of documentation progress; generation of metric reports. Position will receive direction and support. For this special project: We urgently have to implement a new process in line with the Data Integrity requirements within MSD. Therefore, information/documents must be collected from production/lab and translated into actions in order to come to the new process. With a short due date: march 2019.
In 1923, Saal van Zwanenberg started Organon, where at that time pancreatic porcine insulin was purified. It was the start of over 90 years of innovative pharmaceutical production in Oss. Approximately 1,500 colleagues currently work on the production and development of medicines at two locations.
Quality Operations (QO) at MSD Biotechnology operations Oss has the following sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents HUB. The QO Department must ensures adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of MMD products according to MMD Policies, Guidelines & Procedures and regulatory requirements by appropriate oversight and monitoring.
Provides day to day support for Biotech Operations, raising concerns if needed or directing users to do so. In co-operation with functional areas and in line with quality procedures and guidelines, support the handling of deviations, including implementation of CAPA’s. Partner with internal and global groups for technical issues resolution related to investigations or system issues.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to MSD.
Our benefits are very competitive and designed around your preferences:
- A competitive salary depending on experience;
- Extensive set of tools to drive your career, such as a personal development budget, training and coaching;
- Healthy work-life balance.
High level technical writing skills, advanced PC skills such as Excel, MS Access, Word, PowerPoint. Familiarity with automated approval systems such as Trackwise, Documentum etc.
Important: Project skills: ability to learn real fast new processes and motivate people to deliver results for the project. 'Getting things done' is a key term. Ability to structure information and define actions out of it. Ability to work under high pressure and have a flexible mind. Quality is top priority.