Summary
Overview
Work History
Education
Skills
Languages
Certification
Hobbies and Interests
Websites
Interests
Work Availability
Software
Quote
Timeline
StoreManager
Fehim Korkmaz

Fehim Korkmaz

Quality Audit And GMP Compliance Specialist
Istanbul

Summary

Throughout my work in the pharmaceutical industry, I developed my expertise in GMP Compliance and Quality Assurance, leading audits and developing compliance documentation. My proactive approach and teamwork contributed significantly to continuous improvement strategies, ensuring high standards in quality management and regulatory compliance.

Overview

7
7
years of professional experience
5
5
years of post-secondary education
18
18
Certifications

Work History

Quality Audit and GMP Compliance Specialist

Abdi Ibrahim Pharmaceuticals
8 2024 - Current

I participate in internal audits carried out within the company and follow up on action plans and actions. I work together with the auditors in authority and customer audits and ensure the organization for the preparation of CAPA Plans based on the reports submitted after the audit and follow up the actions.

  • Reduced instances of non-compliance through meticulous monitoring of internal controls and periodic audits.
  • Evaluated existing policies regularly, identifying areas for improvement and recommending revisions as needed.
  • Developed strategies for addressing identified gaps in regulatory knowledge within the organization, enhancing overall compliance awareness.
  • Collaborated with other departments to integrate compliance considerations into daily business operations seamlessly.
  • Managed quality programs to reduce overdue compliance activities.
  • Conducted thorough risk assessments to identify potential areas of non-compliance and recommended corrective actions.
  • Stayed current on industry regulations by attending seminars, workshops, and other professional development opportunities.
  • Enhanced company compliance by developing and implementing comprehensive policies and procedures.
  • Promoted a culture of ethical behavior within the organization by underscoring the importance of adhering not only to regulations but also to established company values.
  • Stayed current with latest changes to applicable regulatory standards and company procedures.
  • Reviewed audit and monitoring reports related to consumer and client activities.
  • Prepared documentation and records for upcoming audits and inspections.

Quality Systems Specialist

Vem Pharmaceuticals
02.2023 - 08.2024

I have nearly 4.5 years of experience in Quality Assurance processes. During this period, I have gained and continue to gain experience in Quality Systems and Documentation as well as GMP Compliance team activities. I actively participate as an auditor in internal audits. I personally take part in audit teams in external audits and authority audits. I conduct online audits of active ingredient suppliers. I participate in on-site audits of secondary packaging material suppliers. I ensured the coordination of GMP Compliance personnel reporting to me and followed their work.

  • Enforced GMP throughout facility and monitored continuous compliance to reduce risks.
  • Dealt with non-compliance issues quickly, implementing corrective changes to prevent recurrent problems.
  • Checked documentation met customs, packing and compliance regulations ahead of shipping.
  • Established procedures and controls to keep staff in compliance with accounting standards, regulatory requirements and budget targets.
  • Participated in GMP training of all personnel involved in manufacturing.
  • Escalated any serious breaches of GMP compliance to quality management for appropriate resolution.
  • Undertook regular GMP projects to guarantee company compliance.
  • Verified all documentation accompanying each manufacturing lot for completeness and accuracy according to GMP and ISO guidelines.
  • Trained staff in Good Manufacturing Practices (GMP)s to drive consistently high standards.
  • Demonstrated strong understanding of Good Manufacturing Practices (GMP)s.
  • Implemented risk-based thinking strategies for proactive identification and mitigation of potential issues.
  • Mentored junior team members on best practices in quality systems management, contributing to their professional growth.

Quality Assurance Assistant Specialist

Vem Pharmaceuticals
04.2020 - 02.2023

I actively took part in the internal audits of the areas by taking part in the GMP Compliance team. I took responsibility within the framework of the tasks assigned in the external audits and authority audits. I took part in various tasks in terms of Quality Systems and Documentation. I coordinated and monitored the work of GMP Compliance personnel reporting to me.

  • Participated in GMP training of all personnel involved in manufacturing.
  • Enforced GMP throughout facility and monitored continuous compliance to reduce risks.
  • Escalated any serious breaches of GMP compliance to quality management for appropriate resolution.
  • Verified all documentation accompanying each manufacturing lot for completeness and accuracy according to GMP and ISO guidelines.
  • Trained staff in Good Manufacturing Practices (GMP)s to drive consistently high standards.
  • Demonstrated strong understanding of Good Manufacturing Practices (GMP)s.

Summer Internship

Ege University Department of Medical Pathology
08.2017 - 09.2017
  • Within the scope of the compulsory internship program, I performed my internship in the Immunohistochemistry laboratory. I also took part as an observer in other laboratories of the Department of Pathology. In the Immunohistochemistry laboratory, I made preparations for immunohistochemical staining of incoming biopsy preparations.

Education

Bachelor of Science - Biochemistry (Biotechnology Option)

Ege University
Izmir, Turkey
09.2013 - 06.2018

Skills

Languages

Turkish
Native language
English
Upper intermediate
B2

Certification

SCHOTT FIOLAX ACADEMY - Certificate of Completion

Hobbies and Interests

  • Nature trip
  • Visits to natural beauties and historical sites
  • Watching and playing soccer, basketball, tennis
  • Listening to music
  • Swimming

Interests

Nature trip

Visits to natural beauties and historical sites

Watching and playing football, basketball and tennis

Listening to music

Swimming

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Software

Microsoft Office Word

Microsoft Office Excel

Microsoft Office Powerpoint

SAP

Quote

There is a powerful driving force inside every human being that, once unleashed, can make any vision, dream, or desire a reality.
Tony Robbins

Timeline

Quality Systems Specialist

Vem Pharmaceuticals
02.2023 - 08.2024

SCHOTT FIOLAX ACADEMY - Certificate of Completion

07-2022

ISO 19011:2018 Internal Audit Training (ICTSERT Qualification ID: ITE2018-298)

07-2022

ISO 27001:2013 Information Security Basic and Documentation Training (ICTSERT Qualification ID: BGYS TML-D-182)

07-2022

ISO 27001:2013 Information Security Risk Assessment Training (ICTSERT Qualification ID: BGYS-RSK-579)

07-2022

ISO 9001:2015 Basic Documentation Training (ICTSERT Qualification ID: KYS-15-TD-288)

07-2022

ISO 9001:2015 Quality Management System Process Interaction Training (ICTSERT Qualification ID: KYS-15-PE-921)

07-2022

ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 Basic Training (First Quality Certification Qualification ID: 1301857)

10-2020

ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 Internal Audit Training (First Quality Certification Qualification ID: 1301856)

10-2020

Training of the Trainer (Istanbul Institute of Management Qualification ID: 280603840005)

06-2020

Quality Assurance Assistant Specialist

Vem Pharmaceuticals
04.2020 - 02.2023

Food Safety Training (Pakmaya)

01-2020

ISO 14001 : 2015 - Environmental Management System Internal Auditor (ETC Training & Consultancy Qualification ID: QMAE340120002)

01-2020

ISO 45001 : 2018 - Occupational Health & Safety Management System Internal Auditor (ETC Training & Consultancy Qualification ID: QMAS340120002)

01-2020

ISO 9001 : 2015 - Quality Management System Internal Auditor (ETC Training & Consultancy Qualification ID: QMAQ340120002)

01-2020

GC (Gas Chromatography) (ETC Training & Consultancy Qualification ID: LTGC341219006)

12-2019

HPLC (High Performance Liquid Chromatography) (ETC Training & Consultancy Qualification ID: LTLC341219006)

12-2019

ISO 17025 : 2017 General Requirements For The Competence of Testing and Calibration Laboratories (ETC Training & Consultancy Qualification ID: LAPP341219005)

12-2019

GMP (Good Manufacturing Practices) (ETC Training & Consultancy Qualification ID: GPTM341219006)

12-2019

Summer Internship

Ege University Department of Medical Pathology
08.2017 - 09.2017

Prepatory English Program (Ege University - Pearson Assured Qualification ID: 91139 :MYV03 :G546917: 000101499:19:12:94:ISSUED 18-APR-2015)

05-2015

Bachelor of Science - Biochemistry (Biotechnology Option)

Ege University
09.2013 - 06.2018

Quality Audit and GMP Compliance Specialist

Abdi Ibrahim Pharmaceuticals
8 2024 - Current
Fehim KorkmazQuality Audit And GMP Compliance Specialist