For our client, a company in pharmaceuticals, we are looking for a Technical Specialist - Quality Control based in Leiden.
Our client is looking for 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.
- 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 timelines.
- Leads and drives continuous improvement processes.
- Degree in relevant area, such as Biotechnology, Chemistry, Pharma
- At least 2 - 4 years' experience in comparable position
- Experience with MS, HPLC, cIEF, and cSDS required (in order of importance)
- Fluent in English
- Analytical thinking
- Strong Quality Awareness
- Stress resistant
- Work independently
- Capability to manage multiple priorities and unexpected changes
What do we offer
- Contract via Kelly Services of period (40 hours per week)
- Start date: asap
- An international environment where you can learn a lot in challenging projects
When interested please react through the application process with your English resume.
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Regarding this role, Kelly Services acts as the official temporary employment agency. 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.