APR & Validation Specialist

GENSENTA İLAÇ SAN. VE TİC. A.Ş.

Job Description:

• To prepare the annual validation plans and follow up all activities in a timely manner.
• To prepare process and packaging validation protocols, to evaluate results and written the reports in accordance with the current regulations.
• To prepare protocols of the hold time studies in accordance with the current regulations, to evaluate results and written the reports.
• To 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)
• To 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:

• University 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 GMP.
• 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.
• Prone to teamwork, good communication skills.
• Having a good command of English.
• No military obligation for male candidates.