Bahar Mutlu Email & Phone Number

Istanbul, Turkey

Management of Starting Materials Group, Bulk - Finished Product Group, Microbiological Laboratory and Equipment-SystemsTo ensure ©GLP and ©GMP Compliance for all quality related processes like routine product and starting material analysis, validation, stability, regulatory compliance, change management, deviation management, documentation etc. for the products manufactured in-house according to the local regulations and Related Directives.To support for Q related activities for… Show more Management of Starting Materials Group, Bulk - Finished Product Group, Microbiological Laboratory and Equipment-SystemsTo ensure ©GLP and ©GMP Compliance for all quality related processes like routine product and starting material analysis, validation, stability, regulatory compliance, change management, deviation management, documentation etc. for the products manufactured in-house according to the local regulations and Related Directives.To support for Q related activities for Third Party Manufacturers (Change Handling, Deviation Handling, Process Validation & Stability activities etc.)To give support in terms of Product Quality & Safety related topics (Evaluation of Complaints & Product Recalls)To give support in terms of Supplier qualification related topics (Support the raw material changes projects in order to find alternative manufacturers and cost saving)To give support for preparing KPI of Quality Unit ACHIEVEMENTSo SAP Project; 260 control plans were created in SAP.o Regulatory Compliance Project; Release, Self-Life Specifications and manufacturing processes of 76 Products were re-evaluated by considering approved documents by Minister of Health. o Renovation Project; Re-evaluation of testing methods for all locally manufactured products according to requirements of defined guidelines (state of the art requirements).LEAN SIG SIGMA PROJECTSo Reducing Stability Workload Project–2012- Stability workload was decreased 10 % and the batch number, which is taken for stability studies, was reduced from 35 % to %25.o Optimization of QC Equipment & Device Management Process – workload was decreased 25%o Optimization of QC Processes & Lab Layout- All QC processes was optimized. Show less

Madrid Area, Spain

Exchange of quality processes between SC Alcala and SC Istanbul is a great experience. SC Istanbul manufactures mostly for the local market and considering that SC Alcala is a manufacturer for the global, their management methods and applicable regulations helped me broaden my approach.In an effort to bring out the best case during the short-term assignment, analyzed, reviewed and construed the global directives at both sites and this helped her a lot to gain perspective. Was allowed to… Show more Exchange of quality processes between SC Alcala and SC Istanbul is a great experience. SC Istanbul manufactures mostly for the local market and considering that SC Alcala is a manufacturer for the global, their management methods and applicable regulations helped me broaden my approach.In an effort to bring out the best case during the short-term assignment, analyzed, reviewed and construed the global directives at both sites and this helped her a lot to gain perspective. Was allowed to participate in quality processes at SC Alcala site and therefore engaged in daily routines and controls. Being involved in daily processes also increased her sense of attachment. Show less

Istanbul, Turkey

Supplier QualificationManagement of External Audits & Local Packaging Material Suppliers’ AuditsQuality Management ReviewsLaunch and transfer projects Evaluation of Product Quality Reviews QU Investments

Istanbul, Turkey

Performing all routine microbiological product and raw material tests and also performs all activities of monitoring (environment, water, air, mobs, sinks etc) and qualificationsEvaluating and giving comments on each Change Request/ deviation related with microbiology and following and in case of a need, reporting corrective and preventive actions.

•Implementing and reporting all Microbiological, Physical and Chemical Test for raw materials and finished goods according to relevant standards and providing the documents up-to-date. •Applying TS EN ISO 17025 Quality Management System for Quality Control Laboratory. •Classifying products according to ISO 10993-1 Evaluation of Medical Device and have Preparing the technical files as required by Medical Device Directive (Declaration of Conformity, Product Master Data Files, Clinical… Show more •Implementing and reporting all Microbiological, Physical and Chemical Test for raw materials and finished goods according to relevant standards and providing the documents up-to-date. •Applying TS EN ISO 17025 Quality Management System for Quality Control Laboratory. •Classifying products according to ISO 10993-1 Evaluation of Medical Device and have Preparing the technical files as required by Medical Device Directive (Declaration of Conformity, Product Master Data Files, Clinical Evaluation, Risk Management, etc)•Following stability studies and packaging qualifications included the new projects and validations, etc and contacting European Packaging Laboratory.•Following all labeling issues based on the Medical Device Directive, dealing with the Artwork Center in US. Show less

Istanbul, Turkey

•Preparing the Master Validation Plan annually, to implement and report all process validation (cleaning, packaging, molding, printing, assembling and sterilization) •Involved in all validation studies in production (IQ, OQ, PQ, Gauge R&R, Cpk and Ppk Studies, DFMEA, and PFMEA etc.)