Specialist Mqa Api And Gdp Rp
Current• Review and approval of batch documentation of finished products (API).• Release of intermediates.• Activation of potency results in the OW system. • Activation of raw materials and intermediates products in the OW system. • Reclassification of products in the OW system. • Review and approval from testing of raw materials, intermediate products and finished products in the LIMS system. • Write deviations, incidents, CAPAs, ECs.• Review and approval of deviations, Incidents, CAPAs, ECs and OOXs.• Handling of Customer Complaints.• Handling of returned goods. • Elaboration and maintenance of SOP’s relating to the department. • Keep updated with technical/scientific areas of interest to the department, including authority requirements and GMP-trends. • Assistance to Global Technical Support regarding customer inquiries and to Regulatory Affairs in connection with quality issues. • Perform Quality in API Production (QiP).• Review of process simulation.• Review of monitoring data in relation to release.• Collaborate with production and project managers in projects regarding improvement of GMP and compliance in Xellia.• Elaboration of Annual Product Review (APR).• Participation in audits and inspections.• GDP Responsible Person according to (2013/C 343/01)