As a Technical Specialist that will actively handle the quality and compliance related issues, including medium and high-level deviations, CAPA, NPI GAP assessments and Change Controls. He or she is also responsible to maintain the cGMP compliance- and LEAN status of the team and will act as SME during cGMP inspections and is NPI contact person during the new product implementation process.
The key responsibilities include:
- Acting as lead investigator for local/global Non-Conformances which encompasses conducting the investigation, providing product impact assessments and identifying and defining appropriate corrective and preventive actions.
- Supporting and advising other lead investigators from external and internal QC departments.
- The job holder is responsible for the proper lab investigation and CRA’s for the medium/high-level Quality issues.
- Monitor timely closure of medium/high-level investigations and associated CRA’s.
- The jobholder is responsible for ensuring that assays can technically be executed by the departments concerned in a manner that is efficient, cGMP compliant and safe. This could be accomplished by means of the GAP analysis performed during the new product implementation.
- The jobholder server as an expert on separation technologies and will be requested to represent the team during internal/external meetings. The jobholder will act as a Subject Matter Expert (SME) during audits and inspections and writing observation responses.
- The job holder is responsible for creating URS’s in collaboration with ELM RUN team and provides lab input for the new equipment or technologies in the BUILD team.
- Participates in or lead special projects or studies. Support short- and long-term projects meeting within the established time lines.
- Leads and drives continuous improvement processes.
Our client is part of an international company, and develops and manufactures biologicals aiming to treat diseases in the field of cardiology, immunology and oncology.
The One Lab Laboratories is a combined lab existing out of several test labs. The specified test labs are divided based on specific techniques and/or expertise.
As a part of the ONE Lab situated at the Biologics Manufacturing site in Leiden, the Separation test team is responsible for execution of test methods using various separation techniques, ranging from early clinical up to commercial process control, release and stability.
Functie-eisenWe are looking for candidates with the following qualifications:
- University/Bachelor degree in relevant discipline, e.g. biosciences, pharmacy, (analytical) chemistry with at least 2-4 years of relevant working experience in (bio) pharmaceutical industry
- Experience with MS, HPLC, cIEF, and cSDS required (in order of importance)
- They have good technical writing skills in English
- Good knowledge of statistical data analyses
We are looking for candidates who are highly independent but operate under supervision of management. They take decisions on routine issues independently and decisions on non-routine issues are made in consultation of management
They have strong didactical skills in order to effectively transfer information in a training environment
Employment for 32 – 40 (preferred) hours per week 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.
If you wish to receive more information first, please contact us on firstname.lastname@example.org or 040 - 7999 010
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