Description
We are looking for a
Complaint Manager (m/f)
Reference: -en
Start: ASAP
Duration: 12 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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
Your qualifications
- (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
Skills:
- Compliance manager