Salih Koca

I was the Manager of Solid Production and Packaging Department with a capacity of 250 million boxes. I led 2 Production Supervisor, 18 production specialist, 304 blue-collar workers within the department.

• In the scope of new projects, actively carrying out commissioning activities on behalf of the production and packaging processes (packaging, tablet forms, capsule filling, sachet filling, powder filling, tablet filling) . Additionally, in this context carrying out adaptation for transferring all products to the production and packaging process and process validation for products
• Evaluating new CMO projects, preparing of offer and calculating demanded product cost for CMO project
• Creating production - packaging departments budgets of all factories for a year and to manage
• In the scope of new projects, actively taking role carrying out procurement of equipment, selecting of equipment, doing facility design work and capacity calculation
• Evaluating capacity rising and new investment projects requirement for strategic decision
• Carrying out FAT (factory acceptance test) of equipments by team leader at domestic and international level then carrying out SAT(site acceptance test) of it on site
• Providing coordination with quality and technical departments for production department
• Carrying out implementation, coordination and organization of all production and packaging operations on the basis of quality and efficient to cGMP and other health authorities (euGMP , ME&A , CIS)
• Carrying out production cost reduction and productivity studies
• Being responsible for external audits at the domestic and international level regarding all production and packaging processes
• Managing manufacturing in accordance with the requirements of health regulatory compliance, cGMP rules and HSE rules (ISO 14001)

I was the Manager of Solid and Semi-Solid Production and Packaging Department with a capacity of 75 million boxes (when the equipment is working at full capacity) I led one operation leader, one production specialist, ten blue-collar workers within the department

• In the scope of new projects, actively carrying out commissioning activities on behalf of the production and packaging processes (packaging, tablet forms, capsule filling, sachet filling, cream, gel, ointment, ovule) . Additionally, in this context carrying out adaptation for transferring all products to the production and packaging process and process validation for products
• Evaluating new CMO projects, preparing of offer and calculating demanded product cost for CMO project
• Creating production - packaging departments budgets of all factories for a year and to manage
• In the scope of new projects, actively taking role carrying out procurement of equipment, selecting of equipment, doing facility design work and capacity calculation
• Evaluating capacity rising and new investment projects requirement for strategic decision
• Carrying out FAT (factory acceptance test) of equipments by team leader at domestic and international level then carrying out SAT(site acceptance test) of it on site
• Providing coordination with quality and technical departments for production department
• In the scope of R&D work, actively to take role carrying out adaptation of the product to process and direction
• Carrying out implementation, coordination and organization of all production and packaging operations on the basis of quality and efficient to GMP
• Carrying out production cost reduction and productivity studies
• Being responsible for external audits at the domestic and international level regarding all production and packaging processes
• Managing manufacturing in accordance with the requirements of health regulatory compliance, cGMP rules and HSE rules (ISO 14001)

I was the Supervisor of Non-Sterile Production and Packaging Department with a capacity of 55 million boxes. I led one operation leader, two production specialists, eighty blue-collar workers within the department. I was the project leader of OOE efficiency included Cost Saving, Product Improvement, Technology Transfer projects.

• Planning and realizing production and packaging departments
• Ensuring that Technology Transfer Projects are carried out as project leader
• Ensuring proceeded Improvement Projects by participants
• Ensuring production activities are proceeded in accordance with the quality system and documents
• Preparing all necessary documents for production and ensuring that these documents are available in all areas of use
• Following up training of all employees who work in production area
• Following up required preparation in accordance with audits
• Ensuring cleaning procedures of equipments used in production area in accordance with cleaning validation studies, and adaptation of employees
• Managing of required studies to be able to take preventive actions by identified root cause activities
• Performed collaborative studies with quality departments
• Performing implementations of production efficiency
• Managing manufacturing in accordance with the requirements of health regulatory compliance, cGMP rules and HSE rules (ISO 14001)

I worked in OOE efficiency, Cost saving, Product Improvement, Technology Transfer processes

• Improving processes and specifications of designated products (solid-semi-solid - liquid, gel, ophthalmic and injectable products)
• Implementing of corrective actions for product formulation, process, and primary packaging material in trial studies
• Equipment selecting, planning and risk assessments in batch size increasing projects, coordinating validation studies, and acting as the manager of projects
• Leading alternative source studies for excipient and API's, and coordinating trials and process validation studies
• Ensuring that appropriate processes are designed for production of transfer files by the appropriate equipments in the factory
• Providing process support to customers within the scope of technology transfer products

(09/2016-09/2017) I was the Supervisor of Non- Sterile Oral Penicillin Department with a capacity of 7 million boxes. I led twenty five blue-collar workers within the department

(09/2015-09/2016) I was the Supervisor of Non- Sterile Liquid Department with a capacity of 4 million boxes. I led twenty ten blue-collar workers within the department

• Planning and realizing production and packaging departments
• Ensuring production activities are proceded in accordance with the quality system and documents
• Preparing all necessary documents for production and ensuring that these documents are available in all areas of use
• Following up training of all employees who work in production area
• Following up required preparation in accordance with audits
• Ensuring cleaning that procedures of equipments used in production area are in accordance with cleaning validation studies, and adaptation of employees
• Managing of required studies to be able to take preventive actions though identified root cause activities which performed collaborative studies with quality departments
• Performing implementations of production efficiency
• Managing manufacturing in accordance with the requirements of health regulatory compliance, cGMP rules and HSE rules (ISO 14001)

During the establishment of the new factory, I took a part in softgel, liquid, tablet forms, capsule filling , powder filling, sachet filling, DPI, MDI, sterile parts

• Ensuring Equipments conform with Site Acceptance Test (SAT)
• Participating Process and Cleaning Validation studies
• Ensuring that Scale-Up studies are proceeded with R&D before validation activities
• Preparing and revising Master Batch Records
• Determining primary / secondary packaging material artwork dimensions of local / imported products
• Ensuring that productions are proceeded in accordance with the quality system and documents
• Following up training of the personnel working in production area
• Taking a role in external audits domestic and internationally regarding all production and packaging processes
• Ensuring cleaning procedures of equipments used in production area in accordance with cleaning validation studies, and adaptation of employees
• Managing of required studies to be able to take preventive actions through identified root cause activities which performed collaborative studies with quality departments
• Keeping the production environment safe in according with occupational safety and health rules

I worked as a Production Operator in Granulation, Tablet Compression, Film Coating processes

• Seting up for run, as per batch record
• Making any machine adjustments during a batch run as required
• Performing 'Minor' and 'Major' cleaning compression rooms
• Verifying of ingredients weighed in batch record entries, and reporting any discrepancy to Supervisor
• Controlling calibration status of equipments
• Being responsible for cleaning of production area, rooms and machines
• Informing of the supervisor about equipment malfunctions