Description
Our client, a global pharma/biopharmaceutical organisation is currently seeking additional support with their complaints management in preparation for an FDA audit on their leading manufacturing facility in Austria.Role:
Our client is looking to hire a number of candidates with experience in adverse events / complaint cases with a pharmaceutical manufacturing background.
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.
*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.
*Investigate all major and minor complaints on a timely manner all major/critical complaints to the QAM and the CMO for further investigation.
*Track answers from the CMOs and makes sure those are on time
*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
This is an exciting opening to work in dynamic team in a short / medium length contract opportunity. Please apply now for more details!