warning
İlan yayından kaldırılmıştır

Quality Systems Specialist / Assistant Specialist

GENSENTA İLAÇ SAN. VE TİC. A.Ş.

İstanbul(Avr.)(Bahçelievler)

İş Yerinde

İş Yerinde

Job Type

Full-Time

Position Level

Specialist

Department

Quality

Quality

Application Count

999+ application

Job Type

Full-Time

Position Level

Specialist

Application Count

999+ application

Department

Quality

Kariyer Image

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.

Preferred Candidate

More than 3 years of experience
Bachelor’s(Graduate), Master’s(Graduate)
English(Reading : Advanced, Writing : Advanced, Speaking : Advanced)

Kalite Sistem Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.

Kalite Sistem Uzmanı Kalite Sistem Uzmanı Maaşları Kalite Sistem Uzmanı Nasıl Olunur? Kalite Sistem Uzmanı Nedir? Kalite Sistem Uzmanı İş İlanları
Hakkımızda

Türkiye'nin önde gelen, en eski ve köklü ilaç firmalarından olan ve toplum sağlığı için bir asra yakın bir süredir hizmet veren Gensenta İlaç, 2020 yı

Şirket Sayfasına Git

Kalite Sistem Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.

Kalite Sistem Uzmanı Kalite Sistem Uzmanı Maaşları Kalite Sistem Uzmanı Nasıl Olunur? Kalite Sistem Uzmanı Nedir? Kalite Sistem Uzmanı İş İlanları