XDES is specialist in recruitment van technisch personeel.
We are looking for an Analyst that will active handle the quality and compliance related issues.
Your key responsibilities will be:
1. Deviation management. This includes, but is not limited to:
- Data gathering for assay performance, including raw data. Analyze the assay performance data to relate raw data to assay performance, propose and discuss improvement(s) for the assay(s) with different stakeholders (other sites, DPDS)
- Analyze and update capacity planning including calculated hours required for performance of the different assays.
2. Deviation Management
- 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.
3. Lab Execution
- You are 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.
- You serves as Bioassay expert and will be requested to represent the team during internal/external meetings. You ill act as a Subject Matter Expert (SME) during audits and inspections and writing observation responses.
- You are 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.
- University/Bachelor degree in relevant discipline, e.g. biosciences, pharmacy, (analytical) chemistry.
- At least 2-4 years of relevant working experience in a (bio) pharmacy.
- Good technical writing skill in English
- Good knowledge of statistical data analyses
- Didactical skills in order to effectively transfer information in a training environment.
Salary and Benefits
A great job at an important player in the biopharmaceutical industry.
Contactpersoon voor deze functie is Joost Storms, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: email@example.com Kenmerk: 9578.
- Professionele ontwikkeling