Description de l'offre
Providing active, real time GMP Compliance checks and compliance enforcement during production operations Prepare of self inspection plan and follow up Daily review of event logs created in MES to make sure that all discrepancies and deviations were properly identified and investigated, then acknowledge of these events Thorough and timely investigation of quality deviations, determination of root cause in coordination with related department Assignment and follow-up of corrective and preventive actions Archiving of deviation reports and keeping deviation list updated Trend analysis of the deviations and reporting on a quarterly and annual basis Tracking of CAPAs related to deviations Support Complaint Investigation when needed. To give basic GMP training and trackwise / deviation to related employee To give refreshing trainings whenever required To support the implementation of GMP training program To support the preparation of Annual Product Review / Product Quality Review for each products manufactured at Sandoz Gebze site. Revision of existing SOPs and/or generation of new ones based on the related quality modules To ensure follow up of the actions related to any quality inspection performed by MOH, other Novartis / Sandoz sites and health authorities, preparation and updating of action plans To ensure follow up of self inspection and CFIA actions and updating action plan To ensure that mock audits are performed prior to external audits and deficiencies are eliminated. To ensure perform supplier inspection as needed, follow up of the actions prepared by the company To ensure that GMP requirements defined by MOH, Novartis / Sandoz Quality Manual and policies are met. Keep the confidentiality and originality of all documents. Comply with local regulations related to HSE and Sandoz policies Contribute to saving projects in order to reduce costs, improve new projects and help to complete Quality Assurance related projects Contribute to Total Quality culture with high performance approach
Shift Quality Assurance Spec.
Bachelor Degree English 0-5 years relevant experience
Novartis Technical Operations