Quality Control Supervisor

3 settimane fa

Piemonte, Italia Novartis A tempo pieno

Job Description SummaryThe QC Supervisor supports the QC Head to ensure that Quality Control processes for materials acceptance batches quality control and QC equipment validation / qualification are executed and fully compliant to cGMPs regulation corporate and national guidelines. Major accountabilitiesDeputy of QC Head in managing, coordinating and approving the execution of the analytical activities for batch release and raw materials & packaging materials acceptance according to specifications. Ensure that the stock of materials reagents standards is properly available and ordered; ensure that all QC materials are properly and safely stored, identified, labelled, recorded and monitored according to SOPs and specifications; ensure the correct storage of Reference and Retention Samples of the raw materials and products. In case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures and in case of deviations in collaboration with QC Head perform the investigation and verify the implementation of the related CAPAs. Ensure that all methods used in QC analysis are validated according to SOPs MA and cGMPs; support the QC Head to assure the adequacy of the SOPs of Quality Control department; redact and review SOPs, protocols and reports. Collaborate with QC Head for the redact of stability programs and the annual product review; ensure that the stability analysis are performed on time. Collaborate with QC Head to ensure the initial and periodic training of QC analysts; manage the presence shifts and performances of the QC Technicians when QC Head is not on site. Maintain review and approve the records of the QC activities (i.e. logbook form analytical batch record). Collaborate with QC Head for the periodical self-inspections and external audits (Health Authorities Certified Bodies Supplier); contribute in maintaining the local quality system as per GMPs and corporate guidelines and in assuring the respect of the GMPs and Health Authorities requirements at local level. Guarantee the cleanliness and tidiness and application of Good Laboratory Practice. Ensures high level of attention for handling of radioactive materials within the area of responsibility. Running operations in full compliance with HSE guidelines (internal / external). Support the development and implementation of projects related to new or existing products. Essential requirementsScientific Degree (CTF Pharmacy or Chemistry preferred). Previous experience in a similar role within a GMP lab environment. Available to work in shifts including night shifts and weekends. Language skillsFluent in Italian. Good knowledge of English. Key skillsLaboratory Experience, Quality Assurance, FDA Regulations, ISO 9001, Quality Systems, Microbiology, Quality Control, cGMP, Laboratory Information Management Systems, QA / QC, HACCP, Manufacturing. #J-18808-Ljbffr

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