Biotech and Agricultural Engineering Finance and Economics Management & Business Others Other Science and Tech
1 - 2 Years
As a part of the ONE JSC Lab situated at the Janssen 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.
For our team, we are looking for a Technical Specialist that will active handle the quality and compliance related issues, including medium and high-level deviations, CAPA, NPI GAP assessments and Change Controls. To maintain cGMP compliance and LEAN status of the team. Act as SME during cGMP inspections and is NPI contact person during the new product implementation process.
The key responsibilities of the jobholder:
The jobholder is responsible for deviation management within the Separation team. This includes, but is not limited to:
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.
Executes activities. Large independent, under supervision of management
Decisions on routine issues are taken independently. Decisions on nonroutine issues are made in consultation of management
University/Bachelor degree in relevant discipline, e.g. biosciences, pharmacy, (analytical) chemistry
University/Bachelor degree or Equivalent with at least 2-4 years of relevant working experience in a (bio) pharmaceutica.
Good technical writing skill in English Good knowledge of statistical data analyses Didactical skills in order to effectively transfer information in a training environment.
Netherlands-South Holland-Leiden- Organization
Janssen Biologics (7266) Job Function
Quality Requisition ID
Open Positions from Johnson & Johnson Family of Companies