Experience

Gensenta İlaç

• Türkiye
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Quality Operations Supervisor

  • Nov 2022 - Present

  İstanbul, Türkiye - Responsible for deviation management as QA contact and final approver. - Identify and follow up necessary corrective and preventive actions, perform effectiveness evaluation - Management of organizing contract manufacture operations (Batch records, deviations, change controls, CAPAs, annual product quality review, quality agreements, risk assessments, TCs, contact between departments ) - Prepare, Revise and Review SOPs regarding to Quality Operations/Assurance - Review and Approve… Show more - Responsible for deviation management as QA contact and final approver. - Identify and follow up necessary corrective and preventive actions, perform effectiveness evaluation - Management of organizing contract manufacture operations (Batch records, deviations, change controls, CAPAs, annual product quality review, quality agreements, risk assessments, TCs, contact between departments ) - Prepare, Revise and Review SOPs regarding to Quality Operations/Assurance - Review and Approve Production & Packaging Master Batch Records. - Participate in projects which are QA related, follow up and take actions on time for the projects. - Participate and Review risk analysis for smoke study interventions, media fill interventions and environmental monitoring locations. - Review and approve of smoke study protocols. - Review media fill validation protocols and approve media fill summary reports. - Perform oversight for aseptic area, media fill validations, smoke studies, microbiological environmental controls, manual particle measurement and visual inspection operations. Accordingly identify observations and follow up the required actions - Have knowledge about aseptic interventions and aseptic behaviours - Review and revise Quality Agreements - Participate and Approve Root Cause Analysis (FMEA) as QA contact - Manage line releases after shutdown periods - Review and Approve GMP critical maintenance operations on SAP PM. - Review area/equipment qualification, classification and validation reports. - Responsible for OPEX and Kaizen Coordinator

• Quality Operations Senior Specialist

  • Dec 2021 - Oct 2022

  Turkey

• Quality Operations Specialist

  • May 2017 - Dec 2021

  İstanbul, Türkiye


Mustafa Nevzat İlaç
• Türkiye
• Pharmaceutical Manufacturing
• 100 - 200 Employee
• In-Process Control Analyst

  • Jul 2014 - May 2017