Sedat Denizci

Experience

• 

  Osel Pharmaceutical

  Sept 2005 - Jan 2008

  Production Engineer

  • Confirmation and checking of production of glass bottled serum, PVC bag serum, vial solutions, empty medical vials, empty PVC bags, PVC tube, LHDPE coil, overpouch and medical infusion sets • Weighting of raw materials, preparing solutions, confirmation of filling and packing line start-ups • Keeping and confirming of serial production records of production lines, determination of production aim, efficiency and capacity • Keeping and confirming of production and maintenance records according to ISO 9001:2000, ISO 13485:2003 and cGMP • In-house education of blue collar workers • Taking part as an "auditor" through external supplier audits • Performing IQ-OQ-PQ actions within installment of new equipments Mostrar menos

• 

  BIOFARMA Pharmaceutical

  Jan 2009 - Jan 2012

  Production Specialist

  • Confirmation and checking of dry and wet granulation,tablet pressing,tablet coating, suppository,soft gelatin capsules, vial and parenteral solutions • Weighting of raw materials, preparing solutions, confirmation of filling and packing line start-ups • Keeping and confirming of serial production records • Determination of production aim, efficiency and capacity• Providing of coordination between the production lines • Keeping and confirming of production and maintenance records according to ISO 9001:2000, ISO 13485:2003 and cGMP • Confirmation of Antaresvision 2D barcode systems, preparing work-orders and recipes• Entrance of production datas to the SAP system• Designing and revisioning of standart operation and cleaning procedures • In-house education of blue collar workers • Taking part as an "auditor" through external supplier audits • Performing IQ-OQ-PQ actions within installment of new equipments Mostrar menos

• 

  Sandoz

  Jan 2012 - Jul 2016

  •Management of SDMS user accounts and supporting to SDMS users about system•Preparation of Product Quality Review reports for each products manufactured at Sandoz Gebze-2 site according to PQR plan•Revision of existing SOPs and/or generation of new ones based on the related quality modules•Reviewing of process and cleaning validation protocols and reports•Coordination with other departments for on time cockpit reporting and execution of global reporting•Thorough and timely investigation of quality deviations sourced from raw and packaging materials, determination of root cause in coordination with related department•To connect with the supplier about raw materials and packaging materials errors, to request a report from supplier in accordance with complaints procedures follow-up of corrective and preventive actions•Management of supplier qualification, escalation and recall processes•Establishment of an effective supplier qualification system and ensure that the suppliers of API’s, primary packaging materials and printed packaging materials are audited as required•Management of Quality Risk Assessment Reporting of material suppliers•Management of Annual Supplier Quality Performance Review process•Participating in internal and external audits•Auditing of all manufacturing, testing, storage processes and utility systems against the requirements of Sandoz Quality Manual and local regulations and ensure the elimination of gaps detected during these auditing activities, audit report is written and audit findings are followed up•Follow up of the actions related to my duty related to any quality inspection performed by MOH, other Novartis / Sandoz sites and health authorities, preparation and updating of action plans •Preparation of Quality Agreements with the suppliers of raw materials and packaging materials•Management of IQP Bronze certification project•Participating in Global GDP Excellence Project on behalf of Quality Unit Mostrar menos - Providing active, real time GMP Compliance checks and compliance enforcement during production operations- Supporting production for the initial batch record review including print outs and finalizing the batch record review- Through and timely investigation of production related quality deviations, determination of root cause in coordination with related department in production- Support the follow-up of corrective and preventive actions- Keeping deviation list updated to track the re-occuring deviations periodically and trending the deviations and reporting on a quarterly and annual basis- Tracking of CAPAs and publishing CAPA list on a monthly basis- Identifying of the reoccurring deviations and supporting production for their CAPA proposals.- Support complaint cnvestigation, related with production when needed and implementation of the CAPA’s.- To give basic GMP training to all production employees - To give refreshing GMP 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 site.- Revision of existing SOPs and/or generation of new ones based on the related quality modules- To participate in production departments internal audits Mostrar menos - Providing active, real time GMP Compliance checks and compliance enforcement during production operations- Supporting production for the initial batch record review including print outs and finalizing the batch record review- Through and timely investigation of production related quality deviations, determination of root cause in coordination with related department in production- Support the follow-up of corrective and preventive actions- Keeping deviation list updated to track the re-occuring deviations periodically and trending the deviations and reporting on a quarterly and annual basis- Tracking of CAPAs and publishing CAPA list on a monthly basis- Identifying of the reoccurring deviations and supporting production for their CAPA proposals.- Support complaint cnvestigation, related with production when needed and implementation of the CAPA’s.- To give basic GMP training to all production employees - To give refreshing GMP 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 site.- Revision of existing SOPs and/or generation of new ones based on the related quality modules- To participate in production departments internal audits Mostrar menos

  • Senior Quality Assurance Specialist&GMP Auditor

    Jan 2015 - Jul 2016

  • Senior Quality Compliance Specialist

    Mar 2014 - Jan 2015

  • Quality Compliance Specialist

    Jan 2012 - Mar 2014
• 

  Novartis

  Jan 2016 - May 2022

  • Management of documentation system, SDMS user accounts and supporting to SDMS users about system.• Revision of existing SOPs and/or generation of new ones based on the related quality modules, directives and global procedures.• Coordination of GxP related departments for on time cockpit reporting and execution of global reporting to trace quality KPIs.• Management of supplier qualification, escalation and recall processes• Establishment of an effective supplier qualification system and ensure that the suppliers of API’s, primary packaging materials and printed packaging materials are audited as required• Management of Quality Risk Assessment Reporting of material suppliers• Management of Annual Supplier Quality Performance Review process• Auditing of all manufacturing, testing, storage processes and utility systems against the requirements of Sandoz Quality Manual and local regulations and ensure the elimination of gaps detected during these auditing activities, audit report is written (also entering the audit report to AQWA system) and audit findings are followed up• Follow up of the actions related to my duty related to any quality inspection performed by MOH, other Novartis / Sandoz sites and health authorities, preparation and updating of action plans • Leading of IQP projects in Quality Unit as Quality OpEx Champion• Leading of timely quality deviation investigations, determination of root causes and follow-up of corrective and preventive actions• Leading of trend analysis of the deviations is performed on a quarterly and annual basis and reports are distributed to related units.• Leading of timely and effective batch record reviews at shop floor to prevent possible stock out in market.• Performing annual employee performance reviews and determination of annual targets. Mostrar menos

  • QA Investigation Manager

    Jan 2018 - May 2022

  • Quality Operations Team Leader & GMP Auditor & Operational Excellence Champion

    Jan 2016 - May 2022
• 

  Sandoz

  May 2022 - now

  Senior QA Manager ESO NPS&L