Taliha Beril Ünlü
Commercial Quality Operations Specialist
Siliviri
Summary
Experienced in managing multiple projects simultaneously and being involved in various processes from product production to market launch. Skilled at working in harmony with collaborative teams, ensuring adherence to regulatory requirements and company procedures. A detail-oriented crisis manager with strong organizational skills, committed to continuous improvement and operational excellence.
Overview
7
7
years of professional experience
9
9
years of post-secondary education
3
3
Certifications
1
1
Language
Work History
Commercial Quality Operations Specialist
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
01.2024 - Current
- Ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other regulatory requirements for commercial products.
- Review and approve product specifications, quality documentation to ensure they meet regulatory and quality standards.
- Collaborate with regulatory affairs to ensure products maintain proper market authorization and adhere to local regulatory requirements.
- Ensure that quality control testing is properly executed for all commercial products, including stability testing, batch release testing, and routine quality checks.
- Coordinate with internal and external labs to ensure timely and accurate testing of products.
- Manage and investigate customer complaints related to product quality, ensuring proper documentation, root cause analysis, and corrective actions are implemented.
- Work closely with other departments, including production, supply chain, regulatory affairs, and marketing, to ensure seamless integration of quality practices throughout the product lifecycle.
- Quality agreements for Releasers, Distributors, Warehouses and Customers
- Work closely with other departments to ensure the smooth launch of new products in new markets and supply chain management process.
- Manage the quality processes of contract manufactured products and report to customers
Quality Assurance Specialist
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
İstanbul, Istanbul
08.2021 - 01.2024
- Change system management and follow-up of actions Investigation of customer complaints, determination of root cause and planning of actions
- Carrying out deviation investigations, root cause analysis and planning 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 - Preparation of annual product evaluation reports and carrying out periodic quality assessment studies
- Responsible for supporting the creation and writing of SOPs for other departments when necessary and preparing the general SOPs for quality assurance.
- Carrying 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
Research and Development Specialist
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
İstanbul, Istanbul
03.2021 - 08.2021
- Knowledgee in ICH guidelines
- Validate the methods according to updated monographs
- Develop, validate and document analytical methods
- Execution of process validation protocols for different dosage forms.
- Writing/reviewing of specifications and certifications
- Ability to work closely with people at all levels of the organization
- Manage all analysis and documentation for ministry questions
- Manage analytical method improvement and related analysis processes during the product formula development process
Research and Development Analyst
Abdi İbrahim İlaç Sanayi Tic. A.Ş
İstanbul, Istanbul
03.2018 - 03.2021
- Knowledgee in ICH guidelines
- Validate the methods according to updated monographs
- Develop, validate and document analytical methods
- Execution of process validation protocols for different dosage forms.
- Writing/reviewing of specifications and certifications
- Ability to work closely with people at all levels of the organization
- Manage all analysis and documentation for ministry questions
- Manage analytical method improvement and related analysis processes during the product formula development process
Education
Bachelor of Science - Chemistry
Yıldız Technical University
Istanbul, Türkiye 09.2012 - 06.2017
High School Diploma -
Inönü Anatolian High School
Istanbul, Türkiye 09.2008 - 06.2012
Skills
- SAP
- Qmex
- Microsoft Office Programmes
- Minitab
Certification
TS EN ISO 9001: Quality Management System - Basic, 191053104042
Timeline
Commercial Quality Operations Specialist
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
01.2024 - Current
Quality Assurance Specialist
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
08.2021 - 01.2024
Research and Development Specialist
Abdi İbrahim İlaç Sanayi Tic. A.Ş.
03.2021 - 08.2021
Regulatory in the Pharmaceutical Industry
12-2018
Research and Development Analyst
Abdi İbrahim İlaç Sanayi Tic. A.Ş
03.2018 - 03.2021
TS EN ISO 9001: Quality Management System - Basic, 191053104042
10-2017
TS EN ISO 9001:2015 Quality Management System - Documentation, 191051103884
10-2017
Bachelor of Science - Chemistry
Yıldız Technical University
09.2012 - 06.2017
High School Diploma -
Inönü Anatolian High School
09.2008 - 06.2012