Tolga Aktas

• Project leadership and management of development and transfer projects from initialisation, production of validation batches • Leading the cross-functional project teams • Creation of project plans, leading of project meetings as well as coordination and follow-up of tasks of all involved departments • Main contact person for internal and external customers • Execution of scale-up and transfer of new products into routine production

From the standpoint of Quality Assurance is concerned, my main task is to keep track and manage non-conformities including internal and external complaints that occurred in all HELM subsidiaries around the world. In this regard, corrective and preventive actions were defined by performing root cause analysis based on risk assessment. Within 7 months, I have reduced the number of open cases by around 80% with great teamwork. (contracted job, 5+2 months)

I moved to Hamburg in January 2019 since my wife got an interesting assignment in an international company in Hamburg. During this period, I continue to attend an intensive German course in order to improve myself and adapt to a new culture. I have started job searching activities after getting German certificate B2.

Developing a variety of dosage forms Pre-formulation studies were carried out to set a strategy considering cost-saving commercializing Successful results were obtained from working with CMO The great success was gained in the large scale production by applying a scientific approach to obtained data from trials Authoring of related sections of CTD Due to my organizational skills, the task of scheduling the R&D production areas was fulfilled with a high sense of responsibility

In addition to general main tasks at the last position.; Conducted R&D activities for the development of formulation processes. The R&D running system was reformed complying with the current requirements through great teamwork. Analytical method requirements that belongs to my formulation development projects have been performed. *:The reason for job change was the facility location has been moved to another city

Developed generic drug formulations (characterization of reference product, pre-formulation phase, process validation) Full responsibility to use all pharmaceutical development equipments Responsible for Technology Transfer projects (Formulation and analytical processes) Related part of CTD preparation Worked with international CMO to perform formulation/process development and manufacturing activities *:The reason for job change was the facility location has been moved to another city.

Conducted R&D activities for the development of formulation processes Developed generic drug formulations (cream and liquid, etc.) (characterization of reference product, pre-formulation phase, process validation) Developed analytical methods and performed analytical method validation Preparation and Documentation of all standards, solution and analyzing & follow up. *:The reason for job change was the facility location has been moved to another city.

• Quality control and stability analysis and documentation • Analysis and documentation of transfer and process validation • Validation of analytical methods and cleaning process • Preparation of stability schedules and follow up stability studies • Preparation of process validation protocols and reports • Preparation&Revision of SOPs • Procurement of reactives, devices, replacement parts, etc. *:The reason for job change was the facility location has been moved to another city.

anabin.kmk.org : class H+ (recognized degree in Germany)

(a supportive education / undergraduate minor) anabin.kmk.org : class H+ (recognized degree in Germany)

anabin.kmk.org : class H+ (recognized degree in Germany)