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Annex 1 – Navigating the road to a successful inspection


PharmaLex Cencora Jane Lyons on the new rebrand


Key members of our team

Louise Ui Fhatharta


Quality Management & Compliance

Quality professional with over 20 years’ experience in Microbiology, Quality Control and Quality Assurance  roles in the Pharmaceutical Industry including Sterile Fill Finish and Medical Device. 

Involved in site and laboratory expansion projects from design through to method transfer and operational readiness.  Supported site in a capacity of Quality, Sterility Assurance and Microbiology Lead oversight during projects. Through Industry experience strong analytical and problem-solving skills have been attained and highly developed strong leadership skills. 

Successful experience of leading FDA, HPRA and DEKRA Health Authority inspections. 

Annette Boland

Manager / Consultant

Quality professional with over 30 years’ experience in Quality Operations and Quality Management Systems, holding senior Quality leadership roles in multi-national Pharmaceutical and Medical Device companies with experience across multiple technological platforms including combination products, sterile, solid dosage, and biologics.

Qualified Person and Lead Auditor certified with significant regulatory experience with FDA, HPRA, BSi, leading pre-approval Inspections (new Products / new Facilities) and ongoing routine surveillance Inspections.

Annette has a strategic mindset coupled with a pragmatic approach grounded in a proactive Quality Culture and throughout her career has supported facility start-ups, tech transfer, capacity expansions, acquisitions, decommissioning activities, and has led global quality remediation projects.

Elizabeth Hunt

Communications Manager

Elizabeth Hunt is a veteran of creating and managing digital content to build relationships for organisations and individuals.  She is Communications Manager for PharmaLex, and a keynote speaker for PDA Ireland.

Anne Marie Ireland

Ann Marie Purcell

Commercial Manager

Ann-Marie is a Senior Commercial Manager with 25 years’ industry experience and a demonstrated history of developing key clients and expanding portfolio into existing clients. She is results orientated with a proven ability to manage the delivery of large and complex, internal and outsourced projects from project initiation to transition to operations.

Noelle Clifford PharmaLex Ireland

Noelle Clifford

Manager/Consultant at PharmaLex

Noelle is a qualified and experienced Microbiologist with a BSc (Hons) in Industrial Microbiology from UCD. She has worked within the pharmaceutical industry for over 15 years in Quality Control roles from ground level through to management. Noelle has worked for several multinational pharmaceutical companies gaining experience with Sterile Products, Dry Powder Inhalation Products, Oral Solid Dosage and Topical Products.

Regina Dawkins

Senior Manager – Consultant at PharmaLex UK

Regina Dawkins is the Practice Area Lead for Commercialization Readiness with our Quality Management & Compliance VDC. An experienced Director and Consultant with 30 years in the pharmaceutical industry, working across the UK and Ireland, with a wealth of experience and knowledge in the fields of API’s, Manufacturing (Commercial and Development across various product forms), Storage, Distribution and Transportation. She possesses excellent knowledge of outsourced and global supply chains and can support solution driven technical consultancy on Commercialization readiness for clients entering a new market (EU/US/Australia) for the first time.  

Eilish Kelly Ireland

Eilish Kelly

Consultant/Manager, Quality & Compliance

Eilish Kelly has more than 17 years of experience with regulated licensed sites in the biopharmaceutical and pharmaceutical (solid oral dosage & API) industry. She is widely acknowledged and respected as an expert in Quality Control, Quality Assurance and compliance initiatives focusing on analytical process validation and training. Eilish qualified as a QP and worked previously in a biopharmaceutical facility, in a QA function supporting manufacturing, engineering, QC and warehouse with QP batch release activities involved.

Patrick Nieuwenhuizen Ireland

Patrick Nieuwenhuizen

Director Senior Consultant

Patrick has worked in various Managerial Quality roles in Global Pharmaceutical Companies with over 25 years of experience, covering several platforms including Biologics, Sterile Lyophilisation & Fill Finish, Vaccines and oral Dose. Patrick is a qualified Lead Auditor and SME in Quality Control, Sterility Assurance, New Facility Design / Upgrade, Risk Management

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