Complaint Manager (m/f)

REFERENZNUMMER:

359392/11

IHRE AUFGABEN:

-Ensure that all activities are performed according to the local Quality system and SOPs.
-Management of complaints incl. decision and CAPA setting (preventive and corrective actions)
-Proactive oversight over complaint situation to identify potential clusters and to to eliminate “clusters” and reoccurrence
-Assure complete and correct complaint documentation within predefined deadlines (according to local QA KPIs) including pro-active follow-up of actions
-Check of feedbacks for plausibility and completeness, conversion in official response to customers (i.e. CPOs)
-Support during inspections and questions regarding complaints
-Participation in quality improvement projects within the scope of complaint handling
-Ensure that complaints and deviations are investigated, decided and follow-up of corrective/preventative actions is ensured according to the local quality SOPs and drug products are re-leased in accordance with the registered specifications and are released to market in accordance with local/international regulations
-Ensure that the complaint handling processes are in-line internal and health authorities expectations
-Input for annual product review respectively product quality review (APR/PQR) and compile complaint summaries for APRs/PQRs in accordance with GMP requirements

IHRE QUALIFIKATIONEN:

-(Technical) university/academy degree in chemistry, pharmacy or equivalent
-Professional experience in quality control/quality assurance or in the manufacturing of pharmaceutical drug products
-Fluency in German, spoken/written
-Very good English knowledge, spoken/written

WEITERE QUALIFIKATIONEN:

Compliance manager