You collaborate with a team of quality assurance technicians and batch file proofreaders as well as the various site services.
More precisely, you:
– Evaluate and certify the batches of products manufactured on site according to pharma GMPs
– Evaluate and decide on the actions to be taken following the detection of non-conformities on manufactured products and processes, process and approve deviations in the Trackwise system and propose or validate the associated CAPAs
– Participate, if necessary, in investigations following receipt of external complaints.
You mainly work on the liquid and paste production units and can occasionally work on the dry forms unit.
The objective is the certification of batches as well as the processing of associated quality events.
You report functionally to the Product QA Manager and the Site Quality Unit Manager and to the Pharmacist Responsible for the Operations Quality Department.
You are proficient in digital tools and ideally SAP and Trackwise software.