HABİBE KOCAN DOLAS
Validation/ Quality Assurance
Istanbul
Summary
Dynamic and results-driven professional with extensive experience in pharmaceutical quality assurance and validation, specializing in sterile manufacturing environments. Proven track record of leading successful validation and quality assurance activities while ensuring product quality, regulatory compliance, and operational efficiency. Currently seeking a challenging role where expertise in quality assurance and validation management can be utilized to facilitate continuous improvement and make valuable contributions to the success of an innovative pharmaceutical organization.
Overview
2
2
years of professional experience
3
3
Languages
15
15
years of post-secondary education
Work History
Quality Assurance Supervisor
Rompharm Company
Tekirdağ, 59
1 2016 - 4 2022
- Developed, implemented, and maintained Pharmaceutical Quality Management System (PQMS) to ensure consistent product quality and compliance with national/international regulations and cGMP standards
- Led quality assurance team in establishing and maintaining quality systems
- Led validation team in developing and executing risk-based validation strategies to ensure compliance with regulatory requirements
- Managed and executed all validation/qualification activities, including IQ/OQ/PQ, process validations, aseptic process simulations (APS), cleaning validations, and computerized system validations (CSV), in accordance with validation master plan
- Managed and conducted day-to-day QA activities including deviations, complaints, CAPAs, change controls, batch records review, batch release
- Implemented and monitored quality assurance and validation activities in technology transfer projects as contract manufacturer (CMO), collaborated closely with customer and internal stakeholders
- Conducted external audits managed by regulatory agencies and customers, ensuring timely closure of audit findings and implementation of corrective actions
- Conducted and managed internal and supplier audits to assess adherence to quality standards according to annual audit program and identified areas for improvement
- Responsible for risk management activities effectively to ensure product quality, safety, and process efficiency
- Prepared product quality review reports and collaborated with cross-functional teams to evaluate overall performance and compliance of manufacturing processes and finished products
- Collected trends and prepared site monitoring reports, analyzed monitoring findings with cross-functional team areas for improvement
- Implemented and organized onsite training sessions according to annual training program
- Developed and implemented training plans for team, focusing on enhancing their skills and competencies in quality assurance and validation
- Contributed to regulatory submissions and responses to inquiries from regulatory agencies, supporting product registrations and approvals
- Oversaw qualification of manufacturing/QC equipment, utilities, and computerized systems through risk assessments and validation protocols
- Managed and executed validation activities for new product introductions, ensuring seamless technology transfer and timely market access, collaborating with manufacturing, QC, regulatory affairs, R&D, and customer teams
- Developed cleaning validation procedures, protocols, and worst-case scenario studies based on risk assessments, scientific principles, and regulatory requirements
- Implemented and managed cleaning validation programs for manufacturing lines, collaborating with manufacturing and QC teams to establish robust cleaning procedures and monitoring programs
- Led computerized system validation (CSV) projects, collaborating with IT and operational teams, developing validation protocols, conducting risk assessments, executing validation tests, and preparing validation reports ensuring seamless integration and functionality of computerized systems
- Reviewed and approved all validation documentation, including protocols, reports, and SOPs, ensuring completeness and compliance with regulatory expectations
- Provided validation/qualification technical expertise during regulatory/customer audits, successfully maintaining compliance with regulatory agencies.
Quality Assurance Specialist
Rompharm Company
Tekirdağ, 59
3 2015 - 1 2016
- Led commissioning, qualification, and validation activities for new sterile manufacturing site, equipment, and utilities in accordance with cGMP regulations and company policies
- Collaborated closely with cross-functional teams and stakeholders to perform site acceptance tests (SAT) of equipment and utilities, ensuring alignment with regulatory requirements and corporate quality objectives
- Implemented risk-based validation approaches and developed validation master plans to guide validation activities
- Executed and coordinated installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) of manufacturing, laboratory equipment and utilities in facility in accordance with site Validation Master Plan (VMP)
- Executed and managed aseptic process simulation validation activities for sterile manufacturing site, analyzing results to validate effectiveness of sterile manufacturing processes and identify areas for improvement
- Managed and executed process validation activities for new products of company and contributed to regulatory submissions documents
- Established and implemented pharmaceutical quality management system (PQMS) to ensure consistent product quality and compliance with national/international regulations and cGMP standards
- Ensured that all quality activities; deviations, complaints, change controls, and CAPAs are in compliance with requirements of regulations and guidelines
- Played a key role in health authority GMP & manufacturing license audit, achieving success and earning promotion for expertise in compliance and quality assurance.
- Prepared, reviewed, and updated standard operating procedures (SOPs) and quality documents, including validation/qualification protocols and reports, ensuring thorough and comprehensive documentation within quality system
- Developed calibration part list and calibration master plan for site and organized calibration activities.
Validation Specialist
Laurus Pharmaceutical Industry
Tekirdağ, 59
9 2013 - 3 2015
- Executed commissioning, qualification, and validation activities for new sterile manufacturing facility lines, equipment, and utilities in accordance with cGMP regulations and company policies
- Executed all equipment and system installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of sterile manufacturing facility according to validation master plan (VMP)
- Executed site acceptance tests (SAT) for new equipment in collaboration with cross-functional teams and stakeholders
- Led and performed process validations, cleaning validations, and aseptic processing validations (media-fill), as well as utilities qualifications (HVAC, compressed gas, pure steam, WFI, PW system), and computerized systems validations
- Established and performed IQ/OQ/PQ activities of pharmaceutical traceability systems, ensuring compliance with regulatory requirements, and worked closely with IT teams to ensure system functionality, reliability, and data integrity
- Developed and managed cleaning validation procedures and protocols based on risk assessments, scientific principles, and regulatory requirements, and executed cleaning validation programs for manufacturing lines
- Developed and documented all validation/qualification protocols and reports
- Participated in health authority and customer GMP audits, ensuring closure of audit findings and implementation of corrective actions related to validation/qualification
- Performed GMP compliance activities and internal audits, ensuring that all validation activities are in compliance with current regulations and guidelines
- Assumed responsibility for validation activities in technology transfer projects as CMO
- Conducted annual product quality review reports of licensed and customer products
- Conducted risk assessments for various processes and equipment to minimize their impact on product quality
- Prepared calibration master plan and managed calibration activities according to annual plan.
Quality Assurance Assistant Specialist
Menarini Turkey
Istanbul, 34
03.2011 - 01.2013
- Managed deviations, customer complaints, and CAPA processes, conducted root cause analysis and ensuring timely investigation, resolution, and closure of quality issues
- Responsible for supplier qualification activities and alternative suppliers project, including assessing supplier capabilities, quality systems, and compliance with regulatory requirements
- Organized supplier audits according to annual plan, ensuring timely closure of audit findings
- Prepared product quality review reports according to annual plan
- Conducted thorough review and evaluation of batch records, ensuring timely release and compliance with established specifications, procedures, and regulatory requirements
- Maintained organized and secure archive of quality documentation, ensuring compliance with internal quality standards and regulations throughout document lifecycle
- Responsible for pest control activities on-site according to cGMP and related procedures
- Prepared, reviewed, and updated standard operating procedures (SOPs) and quality documents
- Executed equipment qualification for sterile manufacturing lines, prepared protocol and report of qualifications
- Executed aseptic processing validation activities for sterile manufacturing lines, ensuring compliance with regulatory requirements
- Executed process validations in collaboration with R&D, QC, and manufacturing teams to transfer new processes, and prepared validation protocols/reports.
Education
Master of Science - Pharmaceutical Engineering
Istanbul University
Istanbul, Turkey 09.2012 - 09.2019
Bachelor of Science - Chemical Engineering
Ege University
Izmir, Turkey 09.2001 - 06.2007
Associate of Fine Arts - Photography And Camerawork
Anadolu Universtiy
Eskişehir, Turkey 09.2017 - 06.2019
Skills
Quality Assurance Management
Timeline
Associate of Fine Arts - Photography And Camerawork
Anadolu Universtiy
09.2017 - 06.2019
Master of Science - Pharmaceutical Engineering
Istanbul University
09.2012 - 09.2019
Quality Assurance Assistant Specialist
Menarini Turkey
03.2011 - 01.2013
Bachelor of Science - Chemical Engineering
Ege University
09.2001 - 06.2007
Quality Assurance Supervisor
Rompharm Company
1 2016 - 4 2022
Quality Assurance Specialist
Rompharm Company
3 2015 - 1 2016
Validation Specialist
Laurus Pharmaceutical Industry
9 2013 - 3 2015
Courses Certificates
- Important Regulatory Highlights for Pharma&Medtech for 2023/24,Qualistery,13.12.2023
- Build an Effective Maintenance and Reliability Organization,Qualistery,03.05.2023
- Energy Manager, Ministry of Energy and Natural Resources 08.04.2023
- Guidelines for Creating a Top-Notch Mapping Protocol for GMP and GDP,Qualistery, 26.04.2023
- E-Signatures in Pharma: Challenges, Solutions, and Best Practice,Qualistery, 30.03.2023
- Quality Systems in the Digital Era: Are You Ready for the Future, Qualistery, 23.03.2023
- Thermal Validation, Qualistery, 22.02.2023
- Process Validation, Quality Academia, 29.03.2021
- The Best Change Control Practices, Quality Academia, 26.02.2021
- The Best Deviation, Root Cause Analysis,CAPA Applications,Quality Academia, 21.01.2021
- Selection of Single-Use Components, ISPE, 21.05.2020
- Defining and Achieving Operational Readiness, ISPE,06.05.2020
- Practical Implementation of the Lifecycle Approach to Process Validation,ISPE, 23.04.2020
- Blockchain for Pharmaceutical Engineers, ISPE,19.02.2020
- Data Science Tools for Successful Technology Transfer, ISPE, 11.12.2019
- Data Integrity for Production and Laboratory Equipment, ISPE, 11.04.2019
- Filter and Filtration Process Validation, Sartorius, 10.02.2018
- Excellence in Pharma Engineering, ISPE Turkey, 17.05.2017
- TOC and Cleaning Validation, Atomika Teknik, 05.12.2017
- Engineering Approach at the Facilities of the Future, ISPE Turkey, 26.01.2017
- EN ISO 9001: 2015 Quality Management System Internal Auditor Certificate, TSE, 09.03.2016
- EN ISO 14001:2015 Environmental Management System Internal Auditor Certificate, TSE, 09.03.2016
- New Approaches for Product Design and Production Controls, ISPE Turkey, 21.11.2014
- Cleaning &Sterilization in Pharmaceutical Industry, Gündem A.Ş., 21.05.2014
- Understanding Biologics and Biosimilars: “An Integrated Approach”, ISPE Turkey, 16.05.2014
- Pulmonary Drug Delivery Systems Workshop, ISPE Turkey, 09.05.2014
Projects
- Rompharm Company Turkey Manufacturing Facility Start-Up Project, 03/2015, 09/2016
- UNICEF&Community Volunteers Foundation, Merhaba Yarın Project, Project Responsible, 2005-2007
- Community Volunteers Foundation 8.Youth Council Organization Team Member, 08/2007-09/2007
- Community Volunteers Foundation, Kır Çiçekleri Taştepe Primary School Educational Support Project, Project Responsible, 2005-2006
Personal Information
- Date/Place of Birth: 10/05/1983, Denizli Turkey
- Driving License: Class B, 2008
- Marital Status: Married
References
- Murat Gültekin, Centurion Pharma, Quality Assurance Manager, +90 535 651 5167
- Prof. Dr Erdal Cevher, İstanbul University, Faculty of Pharmacy, Faculty Dean, +90 532 731 12 12, ecevher@istanbul.edu.tr
Courses Certificates
- Important Regulatory Highlights for Pharma&Medtech for 2023/24,Qualistery,13.12.2023
- Build an Effective Maintenance and Reliability Organization,Qualistery,03.05.2023
- Energy Manager, Ministry of Energy and Natural Resources 08.04.2023
- Guidelines for Creating a Top-Notch Mapping Protocol for GMP and GDP,Qualistery, 26.04.2023
- E-Signatures in Pharma: Challenges, Solutions, and Best Practice,Qualistery, 30.03.2023
- Quality Systems in the Digital Era: Are You Ready for the Future, Qualistery, 23.03.2023
- Thermal Validation, Qualistery, 22.02.2023
- Process Validation, Quality Academia, 29.03.2021
- The Best Change Control Practices, Quality Academia, 26.02.2021
- The Best Deviation, Root Cause Analysis,CAPA Applications,Quality Academia, 21.01.2021
- Selection of Single-Use Components, ISPE, 21.05.2020
- Defining and Achieving Operational Readiness, ISPE,06.05.2020
- Practical Implementation of the Lifecycle Approach to Process Validation,ISPE, 23.04.2020
- Blockchain for Pharmaceutical Engineers, ISPE,19.02.2020
- Data Science Tools for Successful Technology Transfer, ISPE, 11.12.2019
- Data Integrity for Production and Laboratory Equipment, ISPE, 11.04.2019
- Filter and Filtration Process Validation, Sartorius, 10.02.2018
- Excellence in Pharma Engineering, ISPE Turkey, 17.05.2017
- TOC and Cleaning Validation, Atomika Teknik, 05.12.2017
- Engineering Approach at the Facilities of the Future, ISPE Turkey, 26.01.2017
- EN ISO 9001: 2015 Quality Management System Internal Auditor Certificate, TSE, 09.03.2016
- EN ISO 14001:2015 Environmental Management System Internal Auditor Certificate, TSE, 09.03.2016
- New Approaches for Product Design and Production Controls, ISPE Turkey, 21.11.2014
- Cleaning &Sterilization in Pharmaceutical Industry, Gündem A.Ş., 21.05.2014
- Understanding Biologics and Biosimilars: “An Integrated Approach”, ISPE Turkey, 16.05.2014
- Pulmonary Drug Delivery Systems Workshop, ISPE Turkey, 09.05.2014
Projects
- Rompharm Company Turkey Manufacturing Facility Start-Up Project, 03/2015, 09/2016
- UNICEF&Community Volunteers Foundation, Merhaba Yarın Project, Project Responsible, 2005-2007
- Community Volunteers Foundation 8.Youth Council Organization Team Member, 08/2007-09/2007
- Community Volunteers Foundation, Kır Çiçekleri Taştepe Primary School Educational Support Project, Project Responsible, 2005-2006
Personal Information
- Date/Place of Birth: 10/05/1983, Denizli Turkey
- Driving License: Class B, 2008
- Marital Status: Married
References
- Murat Gültekin, Centurion Pharma, Quality Assurance Manager, +90 535 651 5167
- Prof. Dr Erdal Cevher, İstanbul University, Faculty of Pharmacy, Faculty Dean, +90 532 731 12 12, ecevher@istanbul.edu.tr