Allemagne 05.07.2022

Deviation Writer


AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies.

We are currently looking for a Deviation Writer in Ludwigshafen

  • Investigation of exception events to determine cause (root cause analysis) including interviewing of involved personnel and assessment for impact
  • Translation of difficult and complex scientific events into a brief and cohesive event report
  • Identification of Corrective and Preventative Actions (CAPAs) to reduce event recurrence
  • Independent generation, review and approval of exception reports and independent
  • planning, coordination and tracking of corrections and CAPAs using the SolTRAQs database
  • Independently ensure implementation of new global and local CAPA requirements
  • QC representative for change control operations in global and local cross-functional teams
  • Fulfilling assigned special functions such as other documentation activities (e.g. SOPs, batch records and other documents) or processing / collaborating in the creation of metrics (Quality Index)
  • Preparation and participation in inspections and audits


 Your profile:

  • Studies in science or training and good knowledge in the pharmaceutical field
  • At least 1 year of practical experience in CAPA management and in handling deviations
  • Strong communication skills. This includes oral and written communication in German and English
  • Experience in the evaluation of (pharmaceutical) analytical results and methods
  • Analytical and careful working methods
  • Excellent team skills
  • Knowledge of Trackwise / SolTRAQs


    AIXIAL informs you that the data we have gathered in this form is indispensable to manage the recruitment process involving the computer processing of your personal data. The collected data may be forwarded to the Group's various entities for the same purposes.
    We remind you that you have a right of access, correction and deletion for the data relating to you, a right of limitation, portability, erasure and opposition for legitimate reasons that you may exercise by sending an email to our DPO at the following address :
    Your personal data is intended for the authorized departments of AIXIAL and it will be retained for a period of 2 years as from our final contact.
    For further details, please consult the AIXIAL Privacy Policy : Data protection policy