Joanna Kapusta
Senior Regulatory Specialist
Głowno
Profil zawodowy
Responsible Regulatory Specialist, passionate about delivering outstanding quality and service. Offering +10 years of experience in industry with history of recognition for performance.
Proven expertise in regulatory dossier preparation (CTD Module 1-3), technical dossier review and in all associated CMC regulatory aspects. Understanding of the pharmaceutical industry, drug development environment, regulatory processes and ICH guidelines and requirements, including EU regulatory framework. Excellent organizational skills, ability to handle multiple tasks, prioritize effectively and deliver high quality output under imposed deadlines, with a strong attention to detail (with emphasis on accuracy and completeness). Flexible and analytical thinking to independently provide solutions to issues and adapt to shifting priorities and timelines.
Podsumowanie
2
2
Languages
6
6
years of post-secondary education
14
14
years of professional experience
Doświadczenie
Senior Regulatory Specialist/ CMC Mature Products
GSK SERVICES SP. Z O.O.
WARSZAWA
05.2023 - Current
- Acting as a Delivery Lead for multiple CMC Variations for Small Molecules, Biopharmaceutical products, Vaccines registered via a variety of procedures in EU and Rest of the World markets (i.a. APAC, EMEA, LATAM, US, CANADA)
- Responding to Health Authority Questions related to CMC topics
- Leveraging regulatory knowledge/experience to respond to content queries, working closely with CMC Strategy Leads (i.a. co-development regulatory concepts & strategies), Supply Chain and other GRA teams, as required
- Project oversight: coordinating meetings with various stakeholders, including production facilities, CMC authors, LOCs and tracking schedules relevant to the progress of the project
- Acting as a mentor for junior colleagues / New Joiners (providing trainings on CMC-related topics, guiding them through all aspects of daily work in the CMC area, including Veeva system)
- Performing quality review of submission dossier to ensure accuracy
Senior Quality Specialist
ORIFARM MANUFACTURING POLAND SP. Z O.O.
ŁYSZKOWICE
06.2022 - 04.2023
- Supporting the development of the organization in the timely implementation of new manufacturers of critical starting and packaging materials - the role of GxP Change Coordinator
- Maintaining good relations with business partners within the corporation (coordination of cooperation between plants aimed at maintaining a stable supply chain for starting materials)
- Management of the Quality Agreement process
- Creation and updating of QMS documentation within the scope of its area or process
- Improvement of the process of timely implementation of CEP documentation for active substances at the plant
- Participation in the quality systems processes (i.a. Change Control, Supplier Qualification, Quality Agreements, Customer Qualification, Self-Inspections, Supplier Audits, Training, Risk Assessment)
- Quality support of raw material transfers
- Participaion in regulatory inspections and external audits from customers
- Participation in the preparation of the Annual Product Quality Review
- Creation and maintaining of quality metrics (KPIs) within the scope of its area/ process and reporting monthly to team leadership
Regulatory Specialist/ Product Variations
HAYS POLAND SP. Z O.O.
WARSAW
05.2022 - 04.2023
- Supporting multiple CMC Variations and source transfers for Finished Products and Active Pharmaceutical Ingredients for Pharma products
- Preparation, technical review, delivery and associated activities of CMC Variations for Finished Products and Active Pharmaceuticals Ingredients for Pharma (Rx) -sections of module 1, module 2 and module 3
- Completing data assessment to ensure compliance of the authored regulatory dossier with GSK regulatory processes and external requirements for local markets e.g. Europe, International countries
- Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossiers on time
- Building and maintaining good relationships with internal and external stakeholders
- Monitoring regulatory intelligence
Quality Specialist
TAKEDA PHARMA SP. Z O.O.
ŁYSZKOWICE
05.2018 - 05.2021
- GxP Change Coordinator (post-registration changes for alternative API and atypical API manufacturers, CEP/ASMF changes, other)
- Acting as a deputy of QA manager (participating in LT daily meetings, communicating risks and solutions to Senior Leaders)
- Managing the Quality Agreements process
- Conducting the process of Supplier Qualification
Senior CMC Specialist and Regulatory Support
TAKEDA PHARMA SP. Z O.O.
ŁYSZKOWICE
01.2018 - 05.2018
- Independent managing post-approval changes in the implementation of new manufacturers of active substances and atypical active substances (e.g. of herbal origin)
- Liaising with starting material manufacturers and suppliers on quality documentation (Module 3) necessary for post-approval processes
CMC Specialist and Regulatory Support
TAKEDA PHARMA SP. Z O.O.
ŁYSZKOWICE
03.2015 - 01.2018
- Preparation of dossier (Module 3) for post-registration changes, renewal of the marketing authorisation for a medicinal products
- Participation in the registration processes of new medicinal products
- Providing opinions on submitted changes to medicinal products, dietary supplements, medical devices from the pharmaceutical manufacturer's side
- Supporting development projects in the regulatory area
- Cooperation with external customers and suppliers in the area of product development and (post-)registration processes
- Monitoring of Polish and European legislation concerning registration procedures for medicinal products
- Verification of compliance of the Manufacturing Documentation with the Registration Documentation
- Supervision over the validity of the list of manufactured medicinal products
- Compilation of internal documentation related to manufacturing in accordance with the requirements of pharmaceutical law and other regulations
- Monitoring of compliance of immediate packaging with current guidelines, regulations regarding food contact materials and articles
- Participation in projects related to second sourcing regarding alternative API manufacturers (ASMF verification and others)
- Participation in the implementation of the requirements of the ICHQ3D guideline 'Elemental Impurities'
- Supervision over compliance of production technology in accordance with the registration dossier of the medicinal product
Intern
PHARMACY
GŁOWNO
07.2012 - 08.2012
Trainee
NYCOMED PHARMA SP. Z O.O.
ŁYSZKOWICE
07.2012 - 08.2012
- Student internships in the Quality Control Department
Wykształcenie
Training in Pharmacoeconomics, HTA, Marketing and Pharmaceutical Law - postgraduate study
BUSINESS SCHOOL WARSAW UNIVERSITY OF TECHNOLOGY
WARSAW 03.2015 - 09.2015
Pharmacy - master's degree
MEDICAL UNIVERSITY
LÓDŹ 10.2008 - 04.2014
Umiejętności
- Regulatory knowledge
- EMA/ICH guidelines
- Regulatory filings expertise
- Pharmaceutical product knowledge
- Biotech regulation knowledge
- Intercultural competence
- Documentation management
- Regulatory compliance understanding
- Excellent written skills
- GMP expertise
- SOPs compliance
- GxP documentation
- Change management
- Customer audits; Authority inspections
- Internal audits
- Risk analysis; Risk mitigation planning
- Interdisciplinary teamwork
LANGUAGES
English
Advanced
C1
Spanish
Beginner
A1
Zainteresowania
- Literature and cinema, particularly drama, true stories and crime
- Mountain hiking and cycling
- Medicinal plants, plant-based treatments and natural medicine
Oś czasu
Senior Regulatory Specialist/ CMC Mature Products
GSK SERVICES SP. Z O.O.
05.2023 - Current
Senior Quality Specialist
ORIFARM MANUFACTURING POLAND SP. Z O.O.
06.2022 - 04.2023
Regulatory Specialist/ Product Variations
HAYS POLAND SP. Z O.O.
05.2022 - 04.2023
Quality Specialist
TAKEDA PHARMA SP. Z O.O.
05.2018 - 05.2021
Senior CMC Specialist and Regulatory Support
TAKEDA PHARMA SP. Z O.O.
01.2018 - 05.2018
CMC Specialist and Regulatory Support
TAKEDA PHARMA SP. Z O.O.
03.2015 - 01.2018
Training in Pharmacoeconomics, HTA, Marketing and Pharmaceutical Law - postgraduate study
BUSINESS SCHOOL WARSAW UNIVERSITY OF TECHNOLOGY
03.2015 - 09.2015
Intern
PHARMACY
07.2012 - 08.2012
Trainee
NYCOMED PHARMA SP. Z O.O.
07.2012 - 08.2012
Pharmacy - master's degree
MEDICAL UNIVERSITY
10.2008 - 04.2014