Sema Oruc

Process Sr. Consultant

GMP | Qualification & Validation | Quality

Summary

Sema has more than 12 years of experience in the pharmaceutical industry. Working in Xellia with different roles from Compliance specialist, production specialist, GMP documentation specialist, Senior Aseptic processing specialist, has made Sema an experience all round profile around the aseptic processing disciplines.

Special Competences

She has a wide range of competences working with daily production, process equipment, changes and validation, optimization and project lead, where she has been responsible for:

• Deviations and systematic problem-solving
• Change request, with or without regulatory impact
• Risk evaluations: QRM, CARA, FMECA, EHS, OHS
• Numerous validations setups and experienced Engineering Responsible and

Operation Responsible
• Requirement setting for new processes or equipment
• Verification steps as DQ, FAT, SAT, IV, OV, testing and PFV

Project Experience

Senior Process Specialist in Final Handling Department
-Project: Optimization of dissolution process to eliminate high impurity level on product -Project: Annex 1 project participation, interpretation, and application of the new Annex 1 -Project: Performing holding time studies for dissolutions and final product (protocol, report)
-Participate in and report on cleaning validation- and sterilization processes.
-Deviation handling and performing related investigations (A3 Problem Solving) -Performing room re-classifications and monitoring
-Qualification of equipment
-Implementing relevant CAPAs, handling of observations
-Performing production investigations for OOX reportsXellia, Denmark – 2022-2023

Xellia, Denmark – 2022-2023