Leyla Cengiz Email and Phone Number

• To support strategic development of QA department regarding cost competitiveness, capacity utilization, ©GMP Compliance• To join in all Projects which are QA related ,follow up and take actions on time for the projects. • To supply that investigations are made to determine the root cause and Corrective /Preventative actions are defined in cases of all deviations, by discussing the problem with related departments, to close up deviations according to related SOPs .• According to priority list of Supply Chain Department, to release bulk materials, raw materials, packaging materials, subsidiary materials and all finished products after controlling of samples and batch documents, if they comply with specifications.• To perform rejection activities in SAP system for all materials which are decided to be rejected ( finished products , bulk products , packaging materials, raw materials, subsidiary materials ). • To provide storage and management of retention samples of products , samples of determined imported products according to the ©GMP rules. • To perform random controls of reference / retention samples according to the ©GMP rules. • To supply the archiving activity of batch documents for all released materials, according to ©GMP rules and local regulations.• To review and approve Production & Packaging Master Batch Records, according to ©GMP rules and to provide compliance to local regulations. To review and approve formulation forms on time and according to ©GMP rules, to provide compliance to local regulations.• To compile QA master data records of finished products, bulk products, subsidiary materials , raw materials , packaging materials ( MES & SAP ) . • To record the new artwork version numbers in MES system . • To perform the batch document review process of batches that customer complaints have been received. • To perform Annual Product Quality Review.

• Controlling and approval of incoming products to warehouse, reviewing batch documentation• Controlling and deciding on return goods• Complaint management and documentation• Taking related actions to prevent the occurrence of any non-conformances relating to product, process and quality systems.• Managing related documentation systems in the warehouse, updating related procedures• Maintaining systems to ensure compliance to company policies, cGDP, cGWP and local regulations• To provide storage and management of retention samples of products , samples of determined imported products according to the ©GMP rules. • To supply the archiving activity of batch documents for all released materials, according to ©GMP rules and local regulations.• To join in all Projects which are QA related ,follow up and take actions on time for the projects. • Maintaining masterdatas of imported products.

• Preparing registration submission files in CTD format, and preparation of GMP files• Preparing correspondences with MOH, Social Security offices and all other governmental authorities• Preparation of variation applications for all approved / unapproved products• Preparation of SmPC/PIL submissions• Preparation of pricing and reimbursement applications for all approved / unapproved products• Follow up all quality assurance reports• Follow up all quality assurance related issues (ITS and warehouse related)• To secure and obtain a proper filing and archiving system• Approval and follow up process of packagings