QA Resources

QA Resources Services:

Validation »
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Quality Systems »
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Quality Audits »
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Vendor Assurance »
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Regulatory Support »
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Documentation Support »
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GMP Genius »
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GMP Training & Coaching »
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Q.A. Resources Team

Carmel Cregan

Carmel is the co-founder of Q.A. Resources Ltd. and has 25 years’ experience working in the pharmaceutical, medical device and healthcare industries. With a degree in Chemistry, Carmel has worked in various quality assurance roles devising, implementing, managing and training in Quality Management Systems. She has an in depth knowledge of industry standards and requirements, with vast experience as a Quality/GMP auditor. Carmel has extensive experience working with companies to implement new or improved supplier management systems including supplier auditing, introducing supplier technical/quality agreements, ongoing supplier monitoring etc. She also works with start-up companies to implement specifically tailored quality systems.

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Catherine O'Brien

Prior to establishing Q.A. Resources in January 2002, Catherine worked as a Quality Systems Manager, Product Release Manager, QP, Microbiologist and Validation Co-ordinator within the pharmaceutical and cosmetics industries. In addition to managing Q.A. Resources, she continues to work in various varied roles on a contract basis within the pharma, medical device and API sectors. Catherine has a BSC (Hons) in Microbiology, a Higher Diploma in Education and a Diploma in Pharmaceutical Manufacturing Technology. She is an experienced Qualified Person and also a Lead Assessor with extensive experience as a quality auditor.

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Bronwyn Kelly

With a BSc (hons) and an MSc in Chemistry, Bronwyn is an exceptionally expert Regulatory Affairs and Quality Assurance professional. She has extensive experience managing Regulatory Affairs departments and liaising with competent authorities in the API, Pharmaceutical and Medical Device sectors. She has co-ordinated the compilation of Product Quality Reviews (PQR)/Annual Product Reviews (APR) as well as the generation and on-going management of Quality/Technical Agreements. She is very experienced working with site QA to assess potential changes, deviations etc. for regulatory impact. She works very well with cross-functional teams as the RA expert.

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Denis Howe

With over 24 years pharmaceutical and medical device experience, Denis is a highly qualified Quality Assurance and Validation Specialist with a wealth of experience in Oral Solid Dose and Medical Device industries. Possessed of excellent communication skills and with a track record in delivering projects on time Denis is strongly focused on meeting and exceeding client’s expectations. Key competencies are Process, Equipment, Cleaning, Software and Analytical Validation, Statistical analysis including Sampling Plans, Process Capabilities, Gauge R&Rs, and implementation of Lean and Six Sigma Methodologies.

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Bonnie Mullally

Bonnie has a Masters degree Biotechnology from UCC and a Diploma in Pharmaceutical Manufacturing Technology (QP) from School of Pharmacy, TCD.  She has experience in the finished pharmaceuticals, API and medical device industries. She has worked as a QP and Quality Manager and has excellent experience managing quality personnel and quality systems. She has a particular in-depth knowledge of devising and implementing effective quality training systems. With excellent interpersonal skills and oral and written communication, Bonnie works well implementing change leading or as part of a team.

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Catherine Kilbane

Catherine is a highly proficient validation engineer and quality auditor. With over 15 years’ experience in pharmaceutical and medical device manufacturing operations, she provides validation expertise in the areas of equipment qualification, process validation and test method validation. Observing the highest standards in GMP, she is an IRCA Certified Lead Assessor with a quality systems auditing background. She has excellent communication skills and a professional approach.  

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Fiona Carson

Fiona has more than 10 years’ experience in the fields of analytical research and development, analytical method validation, stability programme management and analytical instrumentation validation in the pharmaceutical and medical device sectors. With a deep knowledge of regulations, Fiona works well within a GMP/GLP environment. She has set up and managed new laboratories, including the introduction and qualification of new equipment, training of laboratory team and preparing the procedures and systems.

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Siobhan McMahon

Siobhan is an experienced and highly competent Validation Engineer. She had a B Tech. in Production Management and an M Tech. in Computer Integrated Manufacturing. Her experience includes computer system validation, laboratory equipment qualification and implementation of 21 CFR Part 11 compliant systems. She is also experienced in implementation and management of quality systems and quality auditing. She is a qualified trainer and has worked as computer system trainer also.

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Jon Moyle

With an MSc. in Instrumental Analytical Chemistry, Jon is a highly experienced analytical chemist, who has led teams of analytical personnel in many projects. He has a diverse range of instrumental analytical experience including analytical development, method validation, laboratory instrument qualification, method transfer and new laboratory set-up. Jon is an accomplished project and people manager with excellent leadership and interpersonal skills and a proven ability to deliver milestones.

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Alexandra McMahon

Alexandra is a PhD Chemist with much experience as a development chemist implementing PAT solutions in API processes and as part of process improvement and optimisation projects. She also has extensive experience in analytical method validation and laboratory equipment qualification. In addition, she has managed and implemented quality systems as part of quality assurance groups.

Alexandra’s first language is French and she is also fluent in English.

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Deirdre Cahalan

With over 25 years experience in various quality and regulatory roles within the pharmaceutical, API and medical device industries, Deirdre is a versatile and fastidious quality professional. She has very strong experience as a regulatory affairs administrator, documentation reviewer and auditor in contract and full-time roles. She is highly experienced in compiling regulatory submissions, PQR/APR and has effectively managed a number of quality systems including customer complaints and failure investigation. She is a qualified lead assessor.

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Jon Mudd

Jon is a validation and quality assurance expert. He has vast experience in all areas of validation and qualification and is fully versed in all requirements and regulations within the API, pharmaceutical and medical device sectors. He has extensive experience in senior validation, operations and quality management. He has practical approach, always providing solutions. Jon has led many large scale projects and is a great mentor to the teams he leads. Jon also conducts vendor audits on behalf of pharmaceutical multinationals.

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Margaret Foley

Q.A. Compliance & Validation Professional

With over 30 years pharmaceutical and medical device experience, Margaret is a highly qualified Quality Assurance, Regulatory Affairs and Validation Specialist.  She is an extremely organized and pragmatic individual with excellent communication skills.  She has a great reputation for delivering projects on time, meeting and exceeding client’s expectations.  She is adaptable with a wealth of experience in API, Oral Solid Dose and Medical Device industries.

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Agota Bede

Regulatory Affairs Professional

Agota has a Masters degree in Chemical Engineering and a PhD in the field of analytical chemistry from Budapest Technical University.  She has experience in both quality control and quality assurance; she has worked in different industries and in different environments: university; research groups and government bodies.  Since 2004 she has worked in the Pharmaceutical industry specialising in Regulatory Affairs.  Agota, as a Regulatory Manager covered the whole life cycle of a portfolio of products.  She is highly experienced in compiling regulatory submissions and has a particular in-depth knowledge of CMC regulatory submissions, compiling and reviewing documentation.  Agota was involved in process and documentation transfer in multinational companies.  With excellent interpersonal skills she has a practical approach, spotting the problems, finding the solutions and bridging the gaps. 

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Olga Whelan

Q.A. and Validation Support Assistant

Olga is a science graduate with 14 years quality assurance and administrative experience in the regulated Pharmaceutical and Construction Industries.  She possesses a key understanding of the requirements of business and the need to adapt and meet deadlines.  She has efficiently managed and co-ordinated
quality projects and is skilled in protocol and report writing, validation and quality assurance.  She has a professional and ethical approach.

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Padhraig Coyne

Validation / CSV Engineer

Padhraig is an experienced and highly competent Validation Engineer. He holds a B-Eng in Manufacturing Systems Engineering and a Higher Diploma in Software Design. His experience includes computer system validation and quality engineering roles primarily in the medical device industry. More recently he has been working on a Validation Engineering role in the pharmaceutical industry in preparation for an FDA site audit. He is very strong technically having worked in a number of service and equipment roles in the manufacturing and semiconductor industry.  

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What our clients say!

Stryker Ireland has worked with QA Resources since 2007, we have successfully partnered and developed Quality programs and QA Resources Programs
Sarah Hayes - Quality Assurance and Validation Director UCB »
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Q.A. Resources for quality systems implementation and support for implementation of Corporate Quality Standards
Val Buckley - Director of Quality KCI Manufacturing »
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Genzyme have employed a wide range of services from QA Resources over the past 10 years in Genzyme
Eamonn Gleeson - former Head QP and Regulatory Affairs Manager of Genzyme »
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Stryker Ireland has worked with QA Resources since 2007, we have successfully partnered and developed Quality programs and QA Resources Programs
Miriam Garry - HR Manager Training & Compliance of Stryker IRL »
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QA Resources are a highly professional, very capable organization with strong technical competence allied to management skills.
Declan Kelly - former European Vice President of Quality, Genzyme »
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Michael Forkan (Director of Quality NorthStar) Testimonial - QA Resources
Michael Forkan (Director of Quality NorthStar) Testimonial »
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Latest News

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