We are recurring for a a QA expert with expertise in complaints management to support all related activities according to the local Quality system and SOP‟s.
Management of complaints incl. decision and CAPA setting (preventive and corrective actions)
Proactive oversight over complaint situation to identify potential clusters and to eliminate “clusters” and reoccurrence
Assure complete and correct complaint documentation within predefined deadlines and pro-active follow-up of actions
Support during inspections and questions regarding complaints; Support for Self-inspections
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 SOP‟s and drug products are released 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 with internal and health authorities expectations.
Support during inspections and questions regarding complaints; Support for Self-inspections.
Contribution to issuing of quarterly reports and annual reports (complaints)
• (Technical) University/academy degree in chemistry, pharmacy or equivalent
• German: fluently spoken/written
• English: very good knowledge spoken/written
• Professional experience in quality control/quality assurance or in the manufacturing of pharmaceutical drug products
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.