- Manage and coordinate QA function from all aspects.- Leading new product launch activities and leading technical activities related to product transfers.- Management around 40 people with 4 direct reports.

-Manage all the warehousing and distribution activities in accordance with GMP requirements.-Manage lean transformation / operational excellence activities for the warehouses and distribution activities.

- Manage the QA operations team to provide purposeful presence within the operations areas- To be a partner with manufacturing and functional teams- To lead and support operational excellence activities and share best practices- To ensure that QA operations team to be knowledgeable of the operations, processes, products and equipment as well as relevant regulatory requirements and be available to provide guidance regarding deviations as they arise- To ensure that QA operations team to provide immediate feedback to operations regarding incorrect behavior and drive action to improve- To act as Responsible Manager assigned by Turkish Ministry of Health starting from April 2014.- To manage batch release activities as well as to track the performance of adherence to delivery plan.- To be responsible for execution and coordination of recalls and to ensure that written procedures are in place, regularly checked and updated when necessary, in order to organize any recall activity.- To manage the in-process control activities, to ensure that all tests are performed according to approved methods and procedures and the results recorded.- To manage stability testing laboratory activities and investigations

- Manage and coordinate the activities required to meet quality standards and ensure QA system is functioning properly.- Management of batch release process and to ensure adherence to delivery plan.- Handling of authority inspections such as FDA, EMEA, MHRA, GCC and other authorities. - To ensure that all processes and data kept in an audit and inspection ready condition at all times- To ensure supplier qualification program in place and perform technical assessments as well as conducting supplier audits including all over Europe, Far East and Middle East countries.- Negotiate and facilitate the development of Quality Agreements- To ensure that system is available to recall any batch of product and coordinate all activities related to recall- Management of deviation process and to ensure that all non-conformances are fully investigated with using correct tools for root-cause analysis and appropriate measures are taken to prevent reoccurrence.- Management of complaint investigations and to ensure that the cause of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent reoccurrence.- To ensure that self- inspection program in place and inspections are conducted to monitor the implementation and compliance with GMP principles and to propose necessary corrective measures.- Management of training activities basic GMP and all SOP's.- To manage and coordinate process validation activities - Manage and maintain the document management system- Management of change control system

Coordination of general QA activities including coordination of the validations for production equipment and utilities, including preparation of the protocols and summary reports, preparation and handling of inspections.

- Conducting and following up the correspondence for registered and under registration licensed products, making variations required, preparing renewal dossiers.- Supporting QA activities, specifically preparation and handling of inspections and coordination of validation activities.

-Supporting all qualification and start-up activities for the new-built B-lactam derived products plant in coordination with US construction company; Raytheon Engineering & Construction and being a point of contact person for the activities.-Supporting process validation activities after start up, including preparation and execution of the protocols, writing summary reports.