Vacature Technical Specialist Quality Testing in Leiden | Modis
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Technical Specialist Quality Testing

Ref: 14657822

Een week geleden
Vacature locatie
Leiden
Contract type
Detachering

Functieprofiel

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:

Lab Execution

  • 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.

Deviation Management

  • 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.

Bedrijfsprofiel

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 department

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-eisen

We 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

Offer

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.

Connect Smarter.

More information

If you wish to receive more information first, please contact us on technologylifescience@modis.com or 040 - 7999 010

I want to apply now

Please tell us who you are and what motivates you! Send us your using the application button on this website. Closing date is 30 August 2020 at noon.

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