Quality Systems Specialist / Assistant Specialist

 
GENSENTA İLAÇ SAN. VE TİC. A.Ş.
İstanbul(Avr.)

24.08.2022

 

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.

 
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Üniversite (Mezun),Yüksek Lisans (Mezun)
Farketmez
25 - 65

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