Zeynep GÜLEN KINLAK
Bayrampaşa/İSTANBUL
Summary
A well-organized, disciplined, and time-managed person with six years of experience in quality operations. Ability to handle multiple projects simultaneously with a high degree of accuracy. Works hard to perform internal audits and keep the team aligned with requirements and procedures. Detail-oriented team player with strong organizational skills.
Overview
7
7
years of professional experience
6
6
Certifications
Work History
Quality Assurance Team Lead
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
1 2024 - Current
- To monitor the compliance of the areas, processes and personnel practices in the factory with the procedures and GMP rules
- Receiving, evaluating and reporting customer complaints and conducting annual trend analyses
- Receiving and evaluating change notifications, tracking and reporting actions and conducting annual trend analyses
- Receiving and evaluating deviation notifications, following up actions and conducting annual trend analyses
- Supporting the creation and writing of SOPs for other departments as required and preparing general SOPs for quality assurance
- Working in project groups related to quality assurance
- Follow up out-of-specification and out-of-trend situations and share them with the customer
- Preparation of annual product evaluation reports and carrying out periodic quality assessment studies
- Monitoring the corrective actions of the Quality Assurance department
- Accompanying the auditors during their audits
- Completion of annual performance evaluations of suppliers together with Quality Control, Supply Chain and Purchasing departments
- Participating in the audits of domestic and foreign suppliers of materials and services together with the audit team
- Checking and approving changes made to newly created or revised SAP prescriptions
- Coached and motivated seven-person QA team to develop competencies
- Supporting the preparation and writing of SOPs for other departments.
Quality Systems Specialist
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
01.2022 - 12.2023
- Investigation of customer complaints, determination of root cause and planning of actions
- Carrying out deviation investigations, root cause analysis and planning of actions
- Change system management and follow-up of actions
- Carrying out risk assessment studies, determining and following corrective and preventive actions
- Participating in internal and external audits and preparing a CAPA plan after the audit and performing the actions on the targeted date
- Monitoring KPIs on a monthly and annual basis
- Preparation and submission of monthly reports for RFT data and KPIs of customer products
- Responsible for supporting the creation and writing of SOPs for other departments
when necessary and preparing the general SOPs for quality assurance. - Carrying out of OOS and OOT steps, root cause analysis and planning and following of action
- Reduced non-conformance issues by conducting thorough root cause analysis and implementing corrective actions
Quality Systems Engineer
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
01.2021 - 12.2021
- Investigation of customer complaints, determination of root cause and planning of actions
- Carrying out deviation investigations, root cause analysis and planning of actions
- Change system management and follow-up of actions
- Carrying out risk assessment studies, determining and following corrective and preventive actions
- Carrying out of OOS and OOT steps, root cause analysis and planning and following of actions
- Preparation and submission of monthly reports for RFT data and KPIs of customer products
- Preparation of annual product evaluation reports and carrying out periodic quality assessment studies
- Monitoring the corrective actions of the Quality Assurance department
Quality Control Analyst
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
01.2018 - 12.2020
- Performing and reporting finished product analysis
- Performing and reporting analyzes in OOS and OOT processes
- Performing and reporting stability analyzes
- Ensuring and reporting analyzes in accordance with GMP and GLP rules
- To ensure that analyzes are carried out and reported in accordance with data integrity and ALCOA principles
- Ensuring the implementation of the lean production project in the laboratory
Education
MBA - Business Administration
Istanbul Bilgi University
Istanbul,Türkiye 01.2020 - 2021.07
Bachelor of Science - Chemistry
Yıldız Technical University
Istanbul, Turkey 09.2012 - 2017.06
High School Diploma -
Inonu Anatolian Technical High School
Istanbul Turkey 09.2008 - 2012.06
Skills
SAP
QMex
Microsoft Office Programmes
Empower 3
Minitab
QMS
Certification
Customer-oriented, 01/2020, 0000005486
Languages
Turkish
Proficient
C2
English
Proficient
C2
German
Elementary
A2
Additional Information
REFERENCES
Samet ÖZER-Quality Assurance Supervisor
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
Istanbul/Esenyurt
Tel: 05320563885
E-mail: sametozer4@gmail.com
Taliha Beril ÜNLÜ- Commercial Quality Operations Specialist
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
Istanbul/Esenyurt
Tel: 05394554881
E-mail: tberilterzi@gmail.com
Timeline
Quality Systems Specialist
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
01.2022 - 12.2023
Quality Systems Engineer
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
01.2021 - 12.2021
MBA - Business Administration
Istanbul Bilgi University
01.2020 - 2021.07
Quality Control Analyst
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
01.2018 - 12.2020
Bachelor of Science - Chemistry
Yıldız Technical University
09.2012 - 2017.06
High School Diploma -
Inonu Anatolian Technical High School
09.2008 - 2012.06
Quality Assurance Team Lead
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
1 2024 - Current
Customer-oriented, 01/2020, 0000005486
Effective communication, 11/2019, 0000001463
Learning Agility, 09/2019, 0000000905
Regulatory in the Pharmaceutical Industry, 12/2018
TS EN ISO 9001:2015 Quality Management System - Documentation, 09/2017, 231029103321
TS EN ISO 9001:2015 Quality Management System - Basic, 10/2017, 231031103543
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