Deviation Writer

Tasks

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

Requirements

 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