Ayhan Uslu

Responsible for all production and warehouse operations.

I am a management represent for HSE department in my organisation. My responsibilities are, SAFETY - Ensuring the company’s Health and Safety Policy is implemented consistently across the organisation. - Monitoring, evaluating and reviewing Health and Safety policy and practice, make recommendations and implement new policies and procedures as required. - Assisting in the identification of training needs for employees and develop and deliver training as required. - Advising the Board and senior management team on the implications of current andemerging health, safety and welfare legislation, including evaluating options, makingrecommendations and generating actions plans to ensure compliance across theorganisation. - Supporting managers to maintain safe systems, providing specialist advice, coaching and practical support. - Carrying out audits to evaluate the effectiveness of Health and Safety systems andprocedures, and identify and implement improvements. - Investigating, or where appropriate, to assist others to investigate the circumstances andcauses of accidents and take necessary steps to prevent a recurrence. - Taking action to mitigate the impact and likelihood of health and safety risks. - Coordinating the issuing of notifications where required to the Health and Safety Executive. - Preparing regular reports on compliance and activity for presentation to the operationalHealth and Safety Group, the Board and its Sub Committees.

I am responsible for Inhalation,Sterile-liquid, Syrup and suspension,Semi -Solid ointment and Solid cephalasoporin, sterile powder Unit. I am working for a FDA Project currently.

• Acting as a high-level technical resource for interpretation of policy, review and approval of technical documents, and decision making for the quality unit as well as the site Quality. • Oversee activities involved in the review and release of finished product with a focus on compliance to company policies and regulatory standards. • Providing strategy and leadership during regulatory inspections and external audits. • Approving of Change Controls and Deviation Reports. • Reviewing and approving all Validation Protocols and Reports. • Conducting GMP training for staff and insures training is current with all required cGMP regulations. • Coordination with various departments for setting departmental procedures and devising systems for documentation requirements. • Managing Customer Complaints. • Revising, reviewing, and approving SOP's, OOS's, planned and unplanned deviations, CAPA, specifications, Batch Manufacturing Records (BMRs) and all other aspects of cGMP compliance. • Oversee the development of validation programs (IQ/OQ/PQ) • Developing systems for measuring compliance with the company’s quality goals, objectives and standards. Recommend corrective action as required. • Maintaining Annual Product Reviews of the various products being manufactured. • Performing Internal Quality Audits • Monitoring Non-Compliance reports and take corrective actions to assure timely completion.

- Inhaler Production(Dry powder inhalation) - Solid packaging - Sterile Prduction - Non-Sterile Production(Ointment,jel and syrup) - Cef Non -Sterile Production - Cef Powder Sterile Production operations conducted. - Managing and execution of 2 d track and trace project.

I organised all primary and secondary packaging activities in the plant.

I was involved in commisioning and qualification of the water system in the new plant. I also worked as a liquid production chief who is responsible for Plant Water System and Syrup,ointment production.

I started in this position as QA chief dealing with all new factory qualification, validation and startup projects. Especially involved in Water system,Liquid production. I was in a team who work with German Consulting company called Pharmaplan for three years.I was also responsible for documentation unit in a QA department.

I worked as an IPC engineer conducting process control tests and Quality control tests.