İlhan Şengül
Istanbul/Kucukcekmece,34
Summary
18 years of pharmaceutical production and packaging experience in sterile lyophilized / liquid sterile, lyophilized API production, sterile powder filling, sterile ampoule,visual ınspection (manual,semi automatic, automatic ) of sterile products , solid (tablet, film coated tablet, capsule, suspension), drop, syrup, ointment sprays and packaging of all forms with lean manufacturing approach for all processes in conjuction with requlations.
Overview
19
19
years of professional experience
Work History
Production and Planning Supervisor
Gripin Pharmaceuticals
03.2023 - Current
- Responsible for planning of required materials (raw materials,packaging materials) for oral dosage form pharmaceutical productions such as tablets,coated tablets,non sterile liquids,capsules and cachet
- Planning of production lines according to demand of sales department
- Supervising of production staff. Preperation of trainings of personnel
- Preparation and revision of all documents such as Master Batch Records, Standard Operating Procedures, User Requirement Specifications, Process Validation Protocols
- Supervising of technology transfer projects( Preparation of Technology transfer Protocols,Planning of transfer, Establishing team members,providing all required materials, leading all meetings,implementation of transfer, closing and follow up)
- Planning of validation and qualification activities with the related departments
- Planning of maintenance activities of machines
- Enhancing of productivity of lines
Sterile Liquid Production Executive
Sanovel Pharmaceuticals
07.2022 - 03.2023
- Responsible for sterile liquid production, non sterile liquid, ointment production, non sterile cephalosporin production departments.
- Responsible for completing all production and packaging activities in a timely manner.
- Improvement production and packaging activities, identifying bottlenecks points which influences production yield.
- Leading mediafill activities periodically.
- Dealing with quality related issues such as deviation,change control and CAPA.Identfying root causes and implementing corrective and preventive activities.
- Evaluation of technical feasibility of new products to the lines.
- Planning of all production lines in conjunction with other activities such that maintenance, validation, qualification-calibration.
- Management and training of all production staff in order to improve production line performance
- Preparation of annual budget of departments.
Production Supervisor
Menarini Turkey Pharmaceuticals
08.2018 - 07.2022
- Lead production of non sterile dosage form of penicillin products (Tablet,suspension)
- Preparation of production plan in accordance with sales department demand and accomplish all production activities in a timely manner and intended quality level.
- Preparation of personnel training plans.
- Organization of maintenance of all equipments.
- Preparation and revision of all required documents (Master Batch Records, Unit Formulas, Standard Operating Procedures)
- Planning of validation and qualification activities with related departments.
- Supervising of projects such as technology transfer projects of products either from abroad to the Menarini Turkey Facility or from abroad to the contract manufacturing facility in domestic market.
Production Engineer
Abdi İbrahim Pharmaceuticals
03.2018 - 08.2018
- Responsible for production of biotechnology products such as cartridge filling line ( O-Rabs system ), vial ( liquid and lyophilized ) for domestic and foreign markets.
- Lead mediafill practices
- As part of project team member performing training of personnel after FAT
- Preparation of related standard operating procedures of new production areas.
- Participating of projects ( Transfer of new molecules from CMO's and Operational Excellence Activities)
Production Supervisor
Menarini Turkey
12.2015 - 02.2018
- Responsible for production activities of ampoules and eye-ear drops and sterile powder filling operations.
- Planning of production and personnel in order to achieve defined goals.
- Accomplish improvement in documentation.
- Preparation of production related documents (Master Batch Records, Standard Operating Procedures )
- Support Quality Assurance staff in their all qualification and validation activities.
- Establish safety principles in compliance with requlations of EH&S authorities.
Production Supervisor
Mustafa Nevzat
07.2008 - 12.2015
- Production of Oncology products ( Sterile Liquid injectables, lyophilized vials and packaging activities)
- Performing of all SAP activities in order to carry out all production and packaging activities.
- Coordinating staff so as to ensure maximum efficiency through production and packaging operations.
- Ensuring all required activities in order to provide the consistency of production to the regulations.
- Preparation of standard operating procedures, main formula and methods for operations and their revisions. Checking out all batch files.
- Being a part of project teams such as Kaizen,5S,OHSAS
In Process Control Analyst
Deva Pharmceuticals
05.2005 - 07.2008
- Carry out related ın process tests ( weighing, friability, hardness, disintegration, sealing,pH control, visual inspection ) to ensure reliability and quality of products.
- Checking printing ( Serial number,expiry date ) on packaging materials
- Checking out of all Master Batch records before release by QA.
- Being ready to all investigations performed by domestic and foreign health authorities and companies.
Education
Bachelor of Science - Chemistry
Hacettepe University
Ankara, Turkey06.2003
Skills
- Production knowledge
- Pre-Production Planning
- Production Line Management
- Executive Leadership
- Process Improvement
- Project Management
- Problem Solving
- Risk Assessment
Accomplishments
- Graduated with honors from University.
Timeline
Production and Planning Supervisor
Gripin Pharmaceuticals
03.2023 - Current
Sterile Liquid Production Executive
Sanovel Pharmaceuticals
07.2022 - 03.2023
Production Supervisor
Menarini Turkey Pharmaceuticals
08.2018 - 07.2022
Production Engineer
Abdi İbrahim Pharmaceuticals
03.2018 - 08.2018
Production Supervisor
Menarini Turkey
12.2015 - 02.2018
Production Supervisor
Mustafa Nevzat
07.2008 - 12.2015
In Process Control Analyst
Deva Pharmceuticals
05.2005 - 07.2008
Bachelor of Science - Chemistry
Hacettepe University