As a GMP Change Control Specialist 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, coordinating 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 Change Control Specialist, 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 coordinator and responsible for the training-syllabi within the VF;
- Coordinator 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.
- Note: In general, the associate role will typically have ownership on less complex GMP roles and supports the GMP specialists in complex issues or priority projects.
Modis is part of the Adecco Group and is the Professional Staffing/Consulting group and we have Consultants in our team who we second to clients. Currently it employs 500 consultants in the Netherlands and 20,000 worldwide. The focus of Modis Life Sciences is mainly in the direction of QA, QC, USP, DSP, R&D and process profiles within an organization in the field of Biotech, Pharmaceutical industry and Food. We have Consultants working at EMA, Janssen, Sanquin, Astellas, Unilever, Corbion, MSD (Oss and Boxmeer), Aspen and many more!
We have an exciting new job opportunity as a GMP Change Control Specialist at our client based in Leiden.
Our client is a state-of-the-art vaccine manufacturing facility at the Bioscience park in Leiden. They are 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.
Functie-eisenWe are looking for candidates with the following certification and skill set:
- Bachelor’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
- min 2 years relevant work experience in a biotechnology or biopharmaceutical industry environment. Technical background (TU) is also fine.
- 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
- Analytical ability and dealing with complexity
- Good communication in Dutch and English, both verbally and in writing.
- High degree of accuracy, initiative, and independence.
- Flexible, can deal with changing priorities, and stress-resistant.
- Innovative: Continuous innovation of the work processes and working environment.
Planned start date: 01/05/2021 End date: 30/04/2022 Deadline to apply: 23/04/2021
Employment for 32 – 40 (preferred) hours per week for the duration of 12 months. You will be starting at an innovative company. You will be working at a multidisciplinary team of Life Science professionals. You get the opportunity to develop your professional skills. Modis continues to innovate and stimulates new ways of working. In addition to getting a lot of freedom, you also get the necessary responsibilities. This way you are encouraged to continue to develop your ambitions and expertise. In this way we can grow together.
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