Description
Our client, a global pharmaceutical organisation is currently seeking additional support with their complaints management at their manufacturing facility in Germany.The responsibilities include:
*This role requires adherence to specific cGMP requirements and execution according to the valid SOP`s.
*Ensuring compliance according to the internal quality standards, relevant regulatory requirements and the filed product quality standards.
*Ensure that complaints and all respective samples are archived according to guidelines.
*Investigate all major and minor complaints on a timely manner
*Carry out data trending of complaints.
*CAPA setting (preventive and corrective actions) to eliminate clusters and reoccurrence.
*Assure complete and correct complaint documentation including keeping of deadlines (according to local QA KPIs) and GMP-compliance/pro-active follow-up of actions.
*Check all feedback for plausibility and completeness and CAPA`s.
*Provide reporting and overview on the status of all complaints, making sure there are no overdue investigations or CAPA`s.
Skills / Experience
*Strong pharmaceutical / biopharmaceutical experience
*Experience of complaint management
*Monitoring of corrective actions
*Strong written and spoken German (ideal but not essential)
This is an exciting opening to work in dynamic team in a short / medium length contract opportunity. Please apply now for more information.