AB GMP
Advisory

Your trusted partner
for pharmaceutical
quality excellence

 

About

I am an experienced Senior Quality Assurance Specialist with over 12 years in pharmaceutical quality assurance across Ireland’s leading manufacturers, including Amgen, Takeda, Bristol Myers Squibb, and AbbVie. Having completed my MSc in Industrial Pharmaceutical Science (QP Course) at ATU Sligo in October 2025, I am QP-eligible and progressing toward full Qualified Person designation.

My expertise spans sterile biologics, small molecules, and dry powder inhalers, with deep knowledge in technology transfer, process validation, batch record approval, and GMP compliance. I specialize in turning complex quality challenges into practical solutions—whether that’s leading a tech transfer, executing Process Performance Qualification, investigating deviations, or preparing for regulatory inspections.

With additional qualifications including an MSc in Pharmaceutical Business and Technology and a Higher Diploma in Pharmaceutical Production, I bring both technical rigor and real-world operational experience. I excel in high-pressure environments and have a track record of successful project delivery, from manufacturing floor to quality strategy.

Whether you need support with technology transfers, process qualification, compliance programs, or interim quality management, I provide flexible consultancy tailored to your specific needs. Let’s discuss how I can help drive your quality operations forward.

As an experienced Senior QA Specialist with proficiency in manufacturing, QA, compliance, and quality systems, I bring a wealth of expertise to the table. My past roles highlight a diverse skill set, making me a valuable asset in departments such as QA compliance, tech transfers, process qualification, and manufacturing support. Skilled in multitasking and excelling in high-pressure environments, I am capable of handling roles in Tech Services, Market Surveillance, QA compliance, and more. With an educational background including an MSc in Pharmaceutical Business and Technology, a Higher Diploma in Pharmaceutical Production, and a BSc in Chemistry, I am committed to continuous improvement through ongoing education, currently enhancing my skills through a QP course.

See my full resume on LinkedIn

Resume

April 1, 2025

[Amgen]
QA Professional – Technology Transfer & NPI

Dublin, County Dublin, Ireland

To present

April 1, 2025
August 1, 2022

[Takeda · Contract]
Senior Quality Complaints Specialist

Dublin, County Dublin, Ireland

To present

August 1, 2022
January 1, 2022

[Bristol Myers Squibb · Contract]
Senior QA Compliance Specialist

Dublin, County Dublin, Ireland

to Aug, 2022

January 1, 2022
April 1, 2021

[AbbVie]
QA Compliance Engineer

Dublin, County Dublin, Ireland

to Jan, 2022

April 1, 2021
June 1, 2019

[AbbVie]
Pharmaceutical Technology Specialist



to Apr, 2021

June 1, 2019
April 1, 2017

[Allergan]
Compliance & Systems Development Technician



to Jun, 2019

April 1, 2017
January 1, 2013

[Allergan]
Pharmaceutical operator



to Apr, 2017

January 1, 2013

My Services

01.

Regulatory Compliance

Ensure compliance with pharmaceutical regulations and guidelines.

02.

Quality System Development

Develop and implement effective quality systems.

03.

Audits and Inspections

Prepare for audits and inspections with confidence.

Ready to Get Started?

Contact us today to book a consultation

Get In Touch

Address

77 Lower Camden Street, D02XE80, Dublin, Ireland

Phone

+353 85 745 1150

Email

andrzej.bardonski@abgmp.ie

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AB GMP ADVISORY

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