Quality Assurance Specialist

GENSENTA İLAÇ SAN. VE TİC. A.Ş.
City: Kocaeli

Advertisement Date:04.11.2021

Qualifications

Job Description:

• Perform all activities completely in accordance with the quality system and GMP rules.
• Prepare the master batch records.
• Evaluate batch records and make the release decision.
• Manage Documentation, Training, Change Control and Corrective Preventive Action systems.
• Investigate deviations and customer complaints, manage root cause analysis studies and track corrective actions taken.
• Carry out internal and external audit activities.
• Report on Quality Assurance issues.
• Follow the validation and qualification activities in the company, prepare and publish the master validation plan.
• Carry out the responsibility of Quality Assurance archives.
• Distribute the documents that have been put into effect when necessary, withdraw and destroy the old revision.

General Qualifications:

• Bachelor’s degree preferably in Chemistry or Chemical Engineering departments of universities.
• Having expert knowledge of quality system and GMP rules.
• Experienced in preparing, duplicating, reviewing and releasing batch records.
• Having knowledge of GMP issues such as deviation, corrective and preventive actions, change,customer complaints management.
• Experienced in document management and training.
• Experienced in internal and external audit activities.
• Being able to use MS Office and SAP programs at an advanced level.
• Having a good command of English language.
• Completed military service for male candidates.

Job Description