Wacker Biotech is the microbial CDMO - specialising in contract manufacturing of therapeutic proteins, vaccines and Live Microbial Products. Our services cover cell banking, process & analytical development and the GMP manufacturing of biologics for clinical & commercial supply.
With over 20 years of experience producing microbial derived proteins and vaccines, Wacker Biotech is a world-leading partner when it comes to manufacturing microbial biopharmaceuticals.
Wacker Biotech is supporting our customer to scale up the production of a Covid19 vaccine candidate - with an initial plan to produce 100 million doses. We need you to play your part in producing the vaccine!
We are hiring now across our Documentalist teams.
The Documentalist is mainly responsible to support the Production team with maintaining the production
documentation, print and review of batch documentation and other generic documentation and to support process improvements of current manufacturing processes from a documentation perspective.
Your tasks:
* Ensure necessary production documentation including ERP is available for the production departments
* (Bioprocessing, Filling & Finishing and Production support) to execute the production processes.
* Continuous monitoring and revision of controlled documents
* Perform review of filled in production documentation
* Coordinate and facilitate document flows
* Support and perform training activities for the production departments
* Writing and supporting of deviations, change controls and corrective actions in Trackwise
* Maintain department owned controlled documents
* Supporting of continuous improvement of documentation, flows and ERP system
* Communicate on planning and execution of all relevant documentation processes with relevant stakeholders
* Coordination of reconciliation, archiving of documents
* Support Product Change over documentation
Your profile:
* At least a Bachelor's (HBO) degree
* Practical experience with documentation processes in a GMP manufacturing environment
* Experience with quality systems (GMP)
* Fluently in Dutch and English (written and verbal)
* Excellent written and verbal skills.
* Team player with a high degree of autonomy
* Communicates well at multiple levels
* Critical thinking skills.
* Proven experience driving quality and compliance in an organization.
* Proven problem resolution skills.
* Showing initiative
* Communication skills (written and verbally)
* Results-oriented way of working
* Planning and organizing
* You reside in and are eligible to work in The Netherlands (valid work permit)
Sustainability is one of WACKER's corporate goals - also as an employer. We want you to remain productive, healthy and successful long term. That is why we offer, for example, comprehensive health management and a variety of advanced training programs and courses for individual development opportunities, alongside a good work-life balance. Naturally, we also have a fair compensation system and above-average social benefits.
Discover more about this exciting opportunity here
For more details contact our recruitment partner Kelly Services:
Sari Steenhauer - 0031 (0)6 33 13 77 46 -
Apply Now
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Regarding this role, Kelly Services acts as the official mediator. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.
