SAP
İlhan Şengül
Chemist
Summary
18 years of pharmaceutical production & packaging experience in sterile lyophilized / liquid sterile lyophilized API production, sterile powder filling in vials, sterile ampoule, visual control ( manuel,semi-automatic,full-automatic) of sterile product forms,solid (oral tablet),drop,syrup,penicilline tablet and suspension,sprays and packaging of all forms with a lean manufacturing approach for all processes in parallel with HS&E practices and financial budget management of related departmants.
Overview
18
18
years of professional experience
8
8
years of post-secondary education
2
2
Certifications
1
1
Language
Work History
Sterile-Liquid Production Executive
Sanovel İlaç San.
İstanbul
07.2022 - Current
- Responsible for the Sterile liquid production,Non-sterile liquid and ointment production and non-sterile Cephalosporin production departments.
- Responsible for completing all production and packaging activities of the related departments timely
- Improvement production and packaging processes,identifying bottleneck points which influences production yield.
- Lead media-fill practices periodically
- Completing all quality related issues such as deviation,change control and CAPA.
- Evaluate technical feasibility of new products launched by R&Ddepartment
- Establish safety principles in compliance with regulations of EH&Sauthorities
- Making production plans in accordance with other department activities such as maintenance,qualification-calibration of equipments and validations.
- Management and training of all the production staff in order to increase production line performance.
- Preparing annual budgets of the departments.
Production Supervisor
Menarini Türkiye
İstanbul
08.2018 - 07.2022
- Responsible for production of non sterile dosage form of penicilline such as tablets and suspensions.
- Preparation of production plan in accordance with sales demands and accomplish the production operations on time and intented quality level
- Preparing of Personnel training plans
- Organizing of maintanance of equipments ,
- Preparation and revision of related documents (Master batch records,unit formulas) investigation of deviations and CAPA activities
- Planning of validations,qualifications activities with the other departments
- Establish safety principles in compliance with regulations of EH&Sauthorities
- Supervising of projects such as technology transfer of products and enhancing of productivity.Technology transfer of products is performed either from abroad to the Menarini Turkey facility or from abroad to the contract manufacturing facilities in domestic market.
Production Engineer
Abdi İbrahim İlaç San. A.Ş.
İstanbul
03.2018 - 08.2018
- Different types of biotechnology products such as cartridge filling line (O-RABS system),syringe (O-RABS system) vial (both in liquid and lyophilized forms in O-RABS system) for both domestic and foreign markets
- Lead media-fill practices periodically
- Establish safety principles in compliance with regulations of EH&Sauthorities
- As part of the project team responsible for training of personnel after FAT .
- Preparation of related Standard Operating Procedures of new production area .
- Participating of some projects (Transfer of new molecules from CMO's ,Operational Excellence activities )
Production Supervisor
Menarini Türkiye
İstanbul
12.2015 - 02.2018
- Sterile liquid (ampoules,eye-ear drops) and sterile powder filling and packaging operations
- Planning of production and personnel in order to achieve most efficient production
- Lead media-fill practices periodically
- Accomplish the improvement in documentation,
- Preparation of all the production records related with sterile liquid and sterile powder production.
- Support the quality assurance staff in their all validation and qualification activities.
- Establish safety principles in compliance with regulations of EH&Sauthorities
- Making sure that all the machines and production equipments are subjected to protective maintenance activities by planning the production and required personnel.
Production Supervisor of Oncology Plant
Mustafa Nevzat İlaç A.Ş.
İstanbul
02.2014 - 12.2015
- Sterile liquid injectables,freeze dried injectables and their packaging processes
- Preparation production plan in coordination with production planning unit by taking into consideration of sales plan.
- Performing all SAP operations in order to carry out production and packaging processes.
- Coordinating the stuff so as to ensure maximum efficiency through production and packaging operations.
- Being into coordination with all other units so that all the operations are comply with the regulations.
- Preperation of standard operation procedures,main formula and methods for operations and their revisions,control of batch files
- Establish safety principles in compliance with regulations of EH&Sauthorities
- Attending to some projects in the company such as lean manufacturing techniques (eg. Kaizen,5S OHSAS ) .
- Making sure that all the machines and production equipments are subjected to protective maintenance process by planning the production and required staff.
In Process Control Analyst
Mustafa Nevzat İlaç A.Ş.
İstanbul
07.2008 - 02.2014
- In charge of controlling each step of operation that is from raw material to the finished product.
- Responsible from carrying out designated In process control tests at sterile powder filling and packaging processes,sterile bulk production and packaging operations and production of oral dosage forms such as tablets,suspension and capsule.
- Being sure of that all the production and packaging processes are carried out comply with current GMP regulations.
- Before the releasing of batches by QA, controlling batch files in order to find out any of nonconformance.
- Carry out calibration tests of the devices that is used for testing.
- Being ready to all the investigations which is carried out by domestic and abroad pharmaceutical authorities.
In Process Control Analyst
Deva İlaç San. A.Ş.
İstanbul
05.2005 - 07.2008
- To ensure the quality and reliability of the products.
- Responsible for ensuring the quality of the products at the each step of processes from raw material input to the finished product output.
- Performing all the designated in process tests which are weighing,friability,hardness,disintegration and size controls at tablet production,weighing,control of sealing,control of pH at suspension production.Weighing and disintegration at the capsule production and finally filling volume,pH ,visual inspection at the sterilized liquid filling process.
- Controlling of the printings such as serial number and expiration date at the packaging process.
Education
Bachelor of Science - Chemistry
Hacettepe University
Ankara 09.1998 - 06.2003
High School Diploma -
Florya Tevfik Ercan Lisesi
İstanbul 09.1995 - 06.1998
Skills
Pre-Production Planning
Accomplishments
- Graduated as honor student from Chemistry department of Hacettepe University.
- Got 90 points (out of 120 points) from TOEFL IBT (May 2013)
Software
QMex
Trackwise
Documentum
Microsoft Office (Word,Excel,Powerpoint)
Certification
The fundementals and applications of ICP and AAS
Timeline
Sterile-Liquid Production Executive
Sanovel İlaç San.
07.2022 - Current
Production Supervisor
Menarini Türkiye
08.2018 - 07.2022
Production Engineer
Abdi İbrahim İlaç San. A.Ş.
03.2018 - 08.2018
Production Supervisor
Menarini Türkiye
12.2015 - 02.2018
Production Supervisor of Oncology Plant
Mustafa Nevzat İlaç A.Ş.
02.2014 - 12.2015
In Process Control Analyst
Mustafa Nevzat İlaç A.Ş.
07.2008 - 02.2014
In Process Control Analyst
Deva İlaç San. A.Ş.
05.2005 - 07.2008
Computer management
03-2004
The fundementals and applications of ICP and AAS
07-2003
Bachelor of Science - Chemistry
Hacettepe University
09.1998 - 06.2003
High School Diploma -
Florya Tevfik Ercan Lisesi
09.1995 - 06.1998