Quality Systems Specialist / Assistant Specialist İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
Job Description:
- Control all GMP related documents (procedures, instructions …etc.) and taken in effective status in document management system.
- Control corrective and preventive actions and approve in CAPA module.
- Prepare annual plan for basic GMP trainings and deliver to all related personnel regularly.
- Control and coordinate all training activities. (new personnel trainings , documents revision trainings …etc.)
- Facilitate meetings and track the pending activities required to support change control implementations.
- Be a quality contact in change management system.
- Prepare the annual validation plans and follow up all activities in a timely manner.
- Prepare process and packaging validation protocols, to evaluate results and written the reports in accordance with the current regulations.
- Prepare protocols of the hold time studies in accordance with the current regulations, to evaluate results and written reports.
- Prepare protocols of cleaning validation studies and to evaluate the results and written reports.
- Prepare the APR plans and prepare annual product review reports, calculate ppk values of each critical quality attributes, to set the trend limits of each parameters of the products.
- Be a member and quality contact of risk assessment studies performed for validation activities or quality based issues. (Good knowledge of FMEA methodology of risk assessments)
- Perform continued process performance (CPV) studies, written the reports in accordance to the current regulations.
- Ensure that the related actions are taken as a result of the prepared APR reports and CPV reports.
General Qualifications:
- Preferably a Bachelor's degree in Chemical Engineering or Chemistry, Bioengineer, Statistics.
- Preferably having at least 3 years of experience in Quality Assurance, Quality Systems and GMP in the pharmaceutical company.
- Good knowledge of English.
- Good knowledge of Minitab, SAP and MS office applications.
- Result-oriented, able to adapt to changing conditions.
- Researcher, open to learning.
- Good analytical thinking and problem solving skills.
- Ability to work in a team environment with excellent verbal and written communication skills.
- No military obligation for male candidates.
Benzer İş İlanları
AR-GE Araştırmacı
Orzaks İlaç ve Kimya San. Tic. A.Ş.
Kalite Güvence Uzmanı
AR-GE Uzmanı
Kalite Güvence Uzmanı
Araştırma Geliştirme / Arge Uzmanı
L'Oréal Türkiye Plant Quality Process Specialist
Junior R&D Clinical Development Specialist
Abdi İbrahim İlaç Sanayi ve Ticaret A.Ş.
Yatırım Projeleri ve GMP Uyum Uzmanı
Araştırma Geliştirme / Arge Uzmanı
GENSENTA İLAÇ SAN. VE TİC. A.Ş. Production Team Supervisor
Novartis Sağlık, Gıda ve Tarım Ürünleri San.
Nitrosamine Coe Specialist
Kalite Güvence Uzmanı
Kalite Güvence Uzman Yardımcısı
Kalite Kontrol Analisti
GENSENTA İLAÇ SAN. VE TİC. A.Ş. Process Quality Specialist / Assistant Specialist
Gensenta İlaç Sanayi ve Ticaret Anonim Şirketi
GENSENTA İLAÇ SAN. VE TİC. A.Ş. Analitik Cihazlar Kalifikasyon Uzman Yardımcısı
Mikrobiyoloji Teknisyeni
Ruhsatlandırma Uzmanı
Ruhsatlandırma Uzmanı
Validasyon ve Kalifikasyon Uzmanı
Validasyon Uzmanı
Tıbbi Cihaz Belgelendirme/Ruhsatlandırma Uzmanı
Ruhsatlandırma Uzman Yardımcısı
Quality Improvement Project Specialist (R&D)
Kalite Güvence Uzmanı
Production Specialist / Asisstant Specialist
GENSENTA İLAÇ SAN. VE TİC. A.Ş. Production Team Supervisor
Kalite Güvence Uzmanı
Kalite Güvence GMP Uyum Uzman / Uzman Yrd.
AR-GE Araştırmacı - Farmasötik AR-GE
Kalite Yönetim Sistemleri Uzmanı
Kalite Güvence Uzmanı
Technology Transfer Specialist / Asst. Specialist
Quality Improvement Project Specialist (Quality)
AR-GE Formülasyon Uzmanı
Medikal Ruhsatlandırma ve Farmakovijilans Uzmanı
R&D Pharmaceutical Development Specialist
Quality Systems Specialist
