GMP Specialist - change control
Janssen Biologics B.V. - Leiden (Nederland)
For our client, Janssen Biologics B.V., we are looking for a GMP Specialist - change control.
This is an opportunity to work with a groundbreaking vaccine manufacturing team!
As an (associate) GMP specialist – Change Control, you will be responsible for the well-structured approach and the progress of GMP Change Controls. You will be the first line support of the Change/Project Lead, co-ordinating and facilitating Change meetings and ensuring that progress is documented in a compliant way.
Additionally, you will also work on maintenance and improvement of general GMP processes, as needed. Examples are support in Quality Deviations and CAPAs, Training, updating general GMP procedures, support in inspections etc.
You collaborate closely with the operations department, the equipment owners and the process engineers and other staff members of the VF. Also, you are a key contact for and work closely with the Quality Department.
As GMP specialist - Change Control, you will be responsible for:
- Writing change controls for the GMP/ EHS systems and VF improvements, and responsible for follow up and timely documentation and completion;
- Keeping general VF GMP documentation up-to-date;
- Support in improvements on production processes and systems within the VF;
- Support lead deviation investigation in documenting product impact analysis and root cause investigation and timely follow up (including CPA records) and completion;
- Training co-ordinator and responsible for the training-syllabi within the VF;
- Co-ordinator of documentation periodic review within the VF;
- Support internal batch release;
- Working precisely, detecting and solving acute problems and communicate possible abnormalities;
- Leading process excellence activities to continuously improve the work as well as personal skills.
Who we're looking for
We would love to hear from you, if you have the following essential requirements:
- Bachelor’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education);
- At least 2 years of relevant work experience in a biotechnology or biopharmaceutical industry environment;
- Experience in Quality Systems, specifically Change Control;
- Working knowledge with cGMP standards is required;
- A preference for experience with Trackwise QEM, Docspace or similar automated systems;
- Good communication in Dutch and English, both verbally and in writing;
- High degree of accuracy, initiative, and independence;
- Stress-resistant and able to deal with changing priorities;
- Innovative: Continuous innovation of the work processes and working environment.
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.
Janssen Vaccine Facility (VF), part of the Johnson & Johnson Family of Companies, is a state-of-the-art vaccine manufacturing facility at the Bioscience park in Leiden, where they proudly produce leading medicines against diseases that have a global impact, such as vaccines against HIV and RSV. The vaccine facility is designed to manufacture drug substance on a 1000 L scale for Phase III and commercial phase.
The GMP Department consists of approx. 14 persons who play a central role within the VF to ensure GMP compliance in support of production, product transfers and improvement projects.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Salary: >3138|
Days of leave: 25 + 11
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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