Desired profileīasic degree in laboratory, manufacturing or relevant discipline (e.g. Lead and support direct reports in line with Novartis values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process. Participate in training and coaching of new and temporary employees in QA and from associated line functions.ġ3. Participate in knowledge exchange within and outside of TRD.ġ2. Collaborate with other associates to support the service function of QA.ġ0. Compile trending reports and suggest conclusions.ĩ. Perform statistical interpretation of trending data collected by QA (e.g. Write and complete GMP relevant documents in own area of responsibility (e.g CoAs, Certificate of Compliance (CoCs), BRR sheets, test scripts, SOPs with extended applicability).Ĩ. Certificate of authenticity (CoA) needs from different customers TEDI formats, etc.).ħ. Inventory Management and Ordering System (IMOS), GLIMS, Technical Research and Development Quality Workflows (TQW), Quality Plan (QP) database, TEDI, Electronic Standard Operating Procedure System (ESOPS), Pathlore), and/or as a contact person to the needs of the line unit (e.g. Act as contact person for QA questions of quality relevant electronic systems (e.g. Propose and survey implementation of agreed preventive actions.Ħ. Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up. Negotiate deficiencies in GMP documents with the line unit. Supervise 0-3 direct/indirect reports or a team.Ĥ. analytical working sheet templates, Global Laboratory Information Management System (GLIMS) specifications).ģ. Perform review and approval of GMP relevant documents derived from approved sources (e.g. manufacturing or packaging master documents, batch records for material manufactured and/or packaged internally or at contractors, TEDI documents, SOPs, analytical raw data, analytical methods, analytical validation protocols and reports, etc.).Ģ. Perform review of GMP relevant documents for compliance with Standard Operating Procedures (SOPs) across several customer groups (e.g. Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and supports adherence to compliance with GMP in TRD.ġ. Support the supervisor in timely release of Good Manufacturing Practice (GMP) relevant documents by an appropriate review and addressing of gaps and questions.
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