SAP
Melisa Şanlı
Quality Assurance Specialist
Summary
Determined Quality Assurance Specialist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
Overview
4
4
years of professional experience
6
6
years of post-secondary education
5
5
Certifications
3
3
Languages
Work History
Quality Assurance Specialist
Abdi Ibrahim Pharmaceuticals
Esenyurt, Istanbul
01.2022 - Current
- Recorded findings of inspection process, collaborating with quality team to implement corrective/preventive actions.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Fixed identified issues to improve workflows.
- Conducted investigations into questionable test results.
- Monitored testing procedures and verified performance of tests according to established item specifications and protocol.
- Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting purposes.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
- Assessed products or services to evaluate conformance with quality standards.
- Collected and analyzed data and initiated improvements to increase security and performance.
- Monitored product standards and quality-control programs.
- Collaborated with management to provide training on improved processes and assisted with creation and maintenance of quality training.
- Reported problems and concerns to management.
- Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.
- Conducted data review and followed standard practices to find solutions.
- Inspected finished goods to verify conformance with customer specifications and company quality standards.
- Wrote and maintained detailed internal documentation on developed systems.
- Created and achieved product quality objectives and met product specifications.
- Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity and other factors.
- Developed validation master plans, process flow diagrams and standard operating procedures.
- Took part in investigation studies within the scope of customer complaints received, cooperating with R&D, Quality Control, Production and Warehouse & Shipping departments, examination of production and packaging protocols, control of batch release records.
- Conducted Quality Impact assessment processes of deviation notification forms, organizing risk assessment meetings with departments and determining corrective/preventive actions and taking risk-reducing actions.
- Inspecting the compliance of internal and external customers with ISO 9001 standards by taking part in internal audit and external audit processes and scoring the suppliers.
- Participated in Quality Management System performance evaluation studies, contributing to the determination of remedial activities.
- Prepared periodic evaluation reports for changes, deviations, CAPA and customer complaints within the scope of the evaluation of Quality Systems processes.
- Checked the compliance of raw material, packaging material, finished product specifications with current regulations, checking that test methods and SOPs are prepared in accordance with GMP.
- Controlled the documents prepared by the departments on the QMEX electronic quality management system.
Quality Assurance Specialist
Cinnagen Pharmaceuticals, Turkey
Kapakli, Tekirdag
01.2021 - 02.2022
- Took part in the start-up team of a company that will carry out the first biotechnological drug production activity in Turkey.
- Established Facility Design Protocol, facility GMP user requirements and facility risk map within the scope of installation activities, Facility Risk Report.
- Collected offers from suppliers to be evaluated for FDA 21 CFR Part 11 and Data Integrity compliance of the equipment to be purchased for Production and Quality Control departments, and participated in the purchasing processes of the equipment.
- Accompanied suppliers in studies within the scope of HVAC qualification and validation and checking IQ, OQ and PQ protocols and reports.
- Created Computerized Systems Validation plan, followed the completion of the qualification processes of the supplied equipment, realization and reporting of validation activities with the departments' system owners in compliance with data integrity.
- Took part in the installation activities of QMEX Electronic Quality Management System and ERP&Warehouse Management System, created URS and validation test protocols, reported validation activities and trained system users, and commissioned the systems in cooperation with IT department.
- Established Quality Assurance Documentation system, created and reviewed Quality Assurance procedures, checked and approved documents created by other departments.
- Took a role in the technology transfer processes of the products delivered to the facility from Iran, managed the product change control processes, determined the actions to be taken.
- Followed the analytical method validation processes of the products to be transferred, accompanied the relevant departments in cleaning and process validation studies.
- Ensured the management of media filling validation studies in the production areas where sterile production conditions are provided.
Quality Assurance Assistant Specialist
Cinnagen Pharmaceuticals, Turkey
Kapakli, Tekirdag
07.2018 - 01.2021
Production Intern
Ali Raif Pharmaceutical Industry Co., Ltd.
Ikitelli, Istanbul
08.2016 - 09.2016
- Ensured the follow-up of Solid Production activities on the basis of personnel, equipment, process and time, keeping monthly records in Office Excel file and reported to the top manager.
- Ensured that equipment URSs, usage and cleaning instructions are written in accordance with GMP and GDP.
Research and Development Intern
Kalekim Chemicals Co. Inc.
Firuzkoy, Istanbul
06.2015 - 07.2015
- Performed paint analysis and test studies.
- Controlled the compliance of the paint test analyzes with Quality Control specifications and took part in improvement studies.
- Took part in new color development studies, took part in the pilot production processes of the developed paint in the R&D laboratory.
Education
Bachelor of Science - Chemical Engineering
Istanbul University
Avcilar, Istanbul, TURKEY 09.2012 - 09.2018
Erasmus+ Programme - Chemical And Process Engineering
Wroclaw University of Technology
Wroclaw, Poland 09.2015 - 02.2016
Skills
Corrective actions
Accomplishments
- Collaborated with team of 5 in the development of Covid-19 Vaccine Project initiated by R&D Team, Ankara University in Turkey.
- As a result of the inspections carried out by the Turkish Ministry of Health, to be able to receive 3 GMP certificates with a quality team of 5 in a company whose establishment activities are still in progress.
- Took part in the design processes of an ERP system that works integrated with the Warehouse Management System, validating the proper functioning of the system and commissioning the system after 3 years.
Software
QMEX
Netsis ERP
WMS
Microsoft Office
Aspen
Autocad
Matlab
Microsoft Visio
Certification
ISO 9001:2015 Quality Management System and Internal Auditor Certificate
Interests
Music
Movie
Singing
Dance
Research
Timeline
ISO 9001:2015 Quality Management System and Internal Auditor Certificate
08-2022
Process and Organization Design with Visio
05-2022
Quality Assurance Specialist
Abdi Ibrahim Pharmaceuticals
01.2022 - Current
Quality Assurance Specialist
Cinnagen Pharmaceuticals, Turkey
01.2021 - 02.2022
Mettler Toledo Data Integrity Certificate of Training
04-2019
Anton Paar Data Integrity and Computerized System Validation Certificate of Attendance
04-2019
Quality Assurance Assistant Specialist
Cinnagen Pharmaceuticals, Turkey
07.2018 - 01.2021
English Course Certificate of Completion
01-2018
Production Intern
Ali Raif Pharmaceutical Industry Co., Ltd.
08.2016 - 09.2016
Erasmus+ Programme - Chemical And Process Engineering
Wroclaw University of Technology
09.2015 - 02.2016
Research and Development Intern
Kalekim Chemicals Co. Inc.
06.2015 - 07.2015
Bachelor of Science - Chemical Engineering
Istanbul University
09.2012 - 09.2018
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