Julia Ziolkowski
Dundalk,Irland
Summary
Accomplished Quality Assurance professional with expertise in GMP compliance, Quality Systems, and QMS implementation, including deviation management, CAPA, change control, and audits. Skilled in ensuring regulatory compliance through documentation oversight, batch record review, and validation, with strong commitment to advancing quality systems and fostering collaborative teamwork in pharmaceutical industry.
Overview
18
18
years of professional experience
2041
2041
years of post-secondary education
Work history
SENIOR QA DOC. CONTROL & TRAINING TEAM LEAD
WUXI BIOLOGICS
Dundalk, Ireland
01.2024 - 09.2025
- Provided leadership, direction, and governance for Changes, Deviation Management, and CAPA Business processes.
- Approved quality-related documents ensuring compliance with regulatory commitments.
- Coordinated cross-functional collaborations, ensuring successful project outcomes.
- Coordinated site program to ensure compliance with Global Quality Standards, driving efficiencies in process.
- Improved team productivity by implementing efficient workflow strategies.
- Monitored quality systems, self-inspection programs, and GMP programs.
- Owned Change and Deviation Management Systems, ensuring alignment with Global Quality Standards.
- Reviewed and approved change controls, deviations, and failure investigations.
- Coordinated and reported site compliance information and management review reports.
- Generated and reported metrics such as observation, backlog, and change control metrics to senior management.
- Provided coaching and mentoring to QA representatives for timely compliance solutions.
- Supported site GMP inspections, ensuring appropriate technical resources were identified.
- Led team of 5, encouraging them to perform to their personal best in their daily tasks and ensuring alignment with company standards.
- Successfully established, maintained, and managed control system for training individuals in specific Quality Systems/ Programs.
- Developed and implemented value-adding, right-sized approaches to Management Reviews in collaboration with Global Quality Systems group.
SENIOR QUALITY MANAGER AND ASSURANCE AND LABORATORY SPECIALIST
MSD (MERCK SHARP & DOHME)
Vienna, Austria
04.2022 - 08.2024
- EU GMP compliance & Quality Systems (deviation, CAPA, change control, risk management)
- Pharmaceutical Quality Systems & QMS implementation
- Batch record review & secondary packaging oversight
- Internal and external audits (GDP, GMP, regulatory)
- Regulatory requirements (GMP, ISO standards, pharmaceutical lifecycle)
- Documentation control, SOPs, QA, TRAs, WI, validation reports
- Laboratory methods (HPLC, GC, qPCR, sequencing, microbiological testing)
- Training, mentoring & team leadership of team of 5 people
- Administered document management system (Mastercontrol), ensuring smooth business operations.
- Fostered positive learning environment with effective classroom management techniques (Mastercontrol, ILTs, OJTs).
- Enhanced company's document management system (Trackwise) by instituting new filing procedures.
- Maintained up-to-date knowledge about latest industry trends and updates relevant to Quality Management (Mastercontrol & Trackwise)
- System Applications (SAP, LIMs)
BIOLOGIST IN PCR LABORATORY
LIFEBRAIN
Vienna, Austria
12.2021 - 03.2022
- Performed regular inventory checks; ensured adequate supplies for uninterrupted lab operations.
- COVID-19 sample validation & evaluation
- Managed lab equipment maintenance, ensuring optimal performance during experiments.
- Training of new employees on various equipment
- HPLC Software
INTERNATIONAL MENTOR
Lund University
Lund , Sweden
03.2019 - 01.2022
- Responsible for insightful suggestions for semester organization for group of 15 students
- Successfully delivered on tasks within tight deadlines.
- Assisted in planning and implementation of extracurricular activities, e.g. sport events, excursions, language cafes and study evenings
- Offered friendly, efficient advice and handled challenging situations with ease.
NURSE AND CARER FOR A FAMILY MEMBER
Home
Vienna, Austria
01.2008 - 06.2020
LABORATORY ASSISTANT
University of Vienna
Vienna , Austria
07.2017 - 10.2017
- Sample preparation and analysis
- Implemenatation of various immunological detection methods
- Utilised various tools such as microscopes during daily processes resulting in precise assessments.
- HPLC Software
- Enhanced laboratory efficiency by maintaining and sterilising lab equipment.
- Increased safety standards with regular risk assessments.
LABORATORY ASSISTANT
University of Vienna
Vienna, Austria
06.2015 - 07.2015
- Nucleic acid sample preparation and identification
- Applied methods: Protein isolation, Gel filtration, ELISA, SDS-Page and HPLC
- Enhanced laboratory efficiency by maintaining and sterilising lab equipment
- Collected samples from different sources, ensuring variety and diversity in tests run.
LABORATORY ASSISTANT
University of Vienna
Vienna, Austria
11.2011 - 01.2012
- Comet assay application to display correlation between beta-carotene and DNA damage.
- Enhanced laboratory efficiency by maintaining and sterilising lab equipment.
- Reduced errors during testing procedures through careful monitoring of experiments.
- Delivered precise measurements using various lab tools to ensure reliable test data.
LABORATORY ASSISTANT
Medical University of Graz
Graz, Austria
08.2010 - 10.2010
- Executed efficient sample preparation techniques
- Bacterial Identification in milk samples (yogurt, cheese, kefir) on microscopes
- Streamlined workflow by managing inventory of laboratory supplies effectively.
- Enhanced laboratory efficiency by maintaining and sterilising lab equipment.
- Conducted routine checks on lab instruments to ensure proper functioning.
- Diligently cleaned instruments and work areas in accordance with sterilization and disinfectant protocol.
LABORATORY ASSISTANT AND DIETICIAN
UKH
Vienna, Austria
02.2009 - 02.2009
- Organization of NutritionDay 2009 at UKH
- Assistance in meal preparation
- Carried out day-to-day duties accurately and efficiently.
- Meal planning and data evaluation for patients (PKU, alcoholism, lactose intolerance)
- NUTS program application
- Used Microsoft Word and other software tools to create documents and clear communications.
LABORATORY ASSISTANT
University of Vienna
Vienna , Austria
07.2008 - 08.2008
- Performed sample preparation
- Sample collection from different sources, ensuring variety and diversity in tests run.
- Utilised various tools such as microscopes during inspection process resulting in precise assessments.
- Utilised molecular biology techniques such as PCR and DNA extraction
- Statistical evaluation of results
- Conducted routine checks on lab instruments to ensure proper functioning.
- Enhanced laboratory efficiency by maintaining and sterilising lab equipment.
Education
Master of Science - Biotechnology
LTH, Faculty of Engineering
Lund 08.2018 -
Master of Science - Nutrition
University of Vienna
Vienna 09.2014 - 02.2019
Bachelor of Science - Nutrition
University of Vienna
Vienna 09.2008 - 09.2014
Bachelor of Science - Molecular Biology
University of Vienna
Vienna 09.2009 - 11.2017
PROJECTMANAGEMENT - Biotechnology
Lund University
LundSUSTAINABILITY COURSE FOR BUILDING DESIGN - Biotechnology
Lund University
Lund Skills
- GMP compliance & Quality Systems (Deviation, CAPA, Change control, Risk management)
- Pharmaceutical Quality Systems & QMS implementation
- Batch record review & secondary packaging oversight
- Internal and external audits (GDP, GMP, regulatory)
- Regulatory compliance (GMP, ISO)
- SOP development, Documentation oversight, Validation documentation
- Training, mentoring & team leadership
- Laboratory methods (HPLC, GC, qPCR, sequencing, microbiological testing)
Personal Information
- Date of birth: 11/10/1987
- Gender: Female
- Nationality: Austrian
Hobbies and Interests
- Participating in different (Ultra)running competitions
- Volleyball
Languages
English
Native
German
Native
Polish
Native
Timeline
SENIOR QA DOC. CONTROL & TRAINING TEAM LEAD
WUXI BIOLOGICS
01.2024 - 09.2025
SENIOR QUALITY MANAGER AND ASSURANCE AND LABORATORY SPECIALIST
MSD (MERCK SHARP & DOHME)
04.2022 - 08.2024
BIOLOGIST IN PCR LABORATORY
LIFEBRAIN
12.2021 - 03.2022
INTERNATIONAL MENTOR
Lund University
03.2019 - 01.2022
Master of Science - Biotechnology
LTH, Faculty of Engineering
08.2018 -
LABORATORY ASSISTANT
University of Vienna
07.2017 - 10.2017
LABORATORY ASSISTANT
University of Vienna
06.2015 - 07.2015
Master of Science - Nutrition
University of Vienna
09.2014 - 02.2019
LABORATORY ASSISTANT
University of Vienna
11.2011 - 01.2012
LABORATORY ASSISTANT
Medical University of Graz
08.2010 - 10.2010
Bachelor of Science - Molecular Biology
University of Vienna
09.2009 - 11.2017
LABORATORY ASSISTANT AND DIETICIAN
UKH
02.2009 - 02.2009
Bachelor of Science - Nutrition
University of Vienna
09.2008 - 09.2014
LABORATORY ASSISTANT
University of Vienna
07.2008 - 08.2008
NURSE AND CARER FOR A FAMILY MEMBER
Home
01.2008 - 06.2020
PROJECTMANAGEMENT - Biotechnology
Lund University
SUSTAINABILITY COURSE FOR BUILDING DESIGN - Biotechnology
Lund University
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