Aytekin Balci

Experience

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  Orva Ilac San. ve Tic. A.S (Pharmaceuticals)

  Jun 2002 - Sept 2010

  Main Activities and Responsibilities: • Management and administration of the blue collar personnel• Production, filling and packaging planning• Surveillance of missing raw materials and consumables, control of the supplies• Manufacturing preparations and controls, monitoring and registration of the process phases, in-process controls• Monitoring and control of all phases from production until the final product. Responsibility for all approvals• New systems start-ups, modification and development of existing systems• Conduction of international correspondences (regarding to production line, equipment and technical issues)• Responsibility for purified water treatment plants (Softener filters, A.C filters, septron modules, reverse osmosis systems, UV systems)• Fill-close and packaging systems• GMP applications Show less Main Activities and Responsibilities: • Analytical and Instrumental analyses• Material and raw material acceptance controls, final product controls and all clearance approvals• Purchase ordering and acceptance of the consumables• Analyses adjustment of new systems• Preparation of SOPs (Standard Operating Procedures)• Stability studies on products and raw materials• Validation studies• Implementation of quality assurance• Management of corrective actions / preventive measures (CAPA)• GLP applications Show less

  • Production Manager

    Jun 2005 - Sept 2010

  • Head of Quality Control

    Jun 2002 - Jun 2005
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  Orhan Boz Tibbi Malz. ve San. A.S (Medical Devices-Pharmaceuticals)

  Feb 2011 - Aug 2011

  Responsible Manager - Quality Assurance Manager

  Medical Device - Pharmaceutical IndustryMain Activities and Responsibilities: • Responsibility for the commissioning of new pharmaceutical products and the conversion / adaptation thereof to the company • Implementation of the requirements of GMP and policy Pharmacopeia (preparation and organization of the validation reports and SOP work)• Responsibility of ensuring the continuity and the need for implementation of ISO 9001 quality assurance system, ISO 13485 Quality Management System• Management of corrective actions / preventive measures (CAPA)• Responsibility for the environmental and waste water, disposal of hazardous and packaging waste• Responsibility for actions regarding to health and safety of the staff and work environment Show less

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  Naturin Nutraceuticals

  Nov 2011 - Aug 2017

  Food Supplements & Phytocosmetics (V-caps, syrups, microgranules, cold pressed oils & essential oils, herbal extracts, body care products, etc.) Main Activities and Responsibilities;• Leading the certification process (ISO 9001 - ISO 22000 - GMP)• Start up and project works at new facility (lab design according ISO 17025 accreditation, facility clean area requirements against quality systems-GMP-ISO-HACCP, machine line projects, etc)• Maintaining quality system procedures (documentation, SOPs and validations)• Implementation of the requirements of GMP-GLP Show less

  • Quality Assurance Manager

    May 2014 - Aug 2017

  • Head of R&D (Phytocosmetic Unit)

    Nov 2011 - Aug 2017
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  Agri Sciences Tarim ve Ilac

  Aug 2017 - now

  Quality Manager

  Agrochemical Company; Plant Protection and Plant Nutrition productsMain Activities and Responsibilities;• Responsibility for leading and giving guidance to all quality related matter and projects internally and externally for the company including quality assessments, auditing and compliance• Decision-making authority about compliance of all materials and products to quality specifications • Establish quality system in direction of quality policy and quality purposes to provide its execution, to improve and to report them • Provide quality accreditation in accordance with national and international norms, to represent the company in quality management system • Manage studies about improving product quality and work with manufacturing to achieve this• Provide sustainability of supplier assessment system • Provide handling of customer feedbacks effectively, to manage product complaints, to specify and report quality problems• Be part of the leadership team that develops and implements the strategic goals • Prepare and actualize annual expenditure budget of the department • Decision-making authority for all expenditures in accordance with department budget• Laboratory Manager of ISO 17025:2017 accreditated laboratory. Show less