Mark McComish BA (Acc), FCA
T: +353 87 231 0186
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Mark McComish, FCA, is Director of Finance and Operations with The Compliance Group. Mark is responsible for the development and implementation of the Company’s business development strategy and for the management of the Company’s experienced team of Consultants. Mark is a Dublin City University graduate and a fellow of the Institute of Chartered Accountants in Ireland. He has spent the last 20 years advises a variety of businesses in the areas of Mergers, Acquisitions, Business disposal, Management Buy-outs, raising finance and restructuring as well as working with many companies to develop and implement their business development and succession strategies. Firstly, as part of the team at one of Ireland’s leading Accountancy Firm, Mazars (formerly “Chapman Flood”) and since 2004 as the Managing Director of Platinum Corporate Finance, Mark has played a key role with client businesses and their owners in growing their business and/or ultimately realising value from their investment.
Stan O’Neill BSc (Pharm), MPSI
T: +353 86 603 2297
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Stan O’Neill is the Managing Director of The Compliance Group. After qualifying as a Pharmacist, Stan spent over five years working in the pharmaceutical industry in Regulatory Affairs, Marketing and Quality Assurance (QP) and then joined the Irish Medicines Board (IMB), now the Health Products Regulatory Agency (HPRA), for a period of ten years. In his capacity as a Senior Inspector, he performed GMP inspections throughout the world, represented Ireland at European level for the negotiation of standards of inspection for medicinal products and trained Inspectors at Irish, European and International levels.
Bernadette O’Brien BSc (Hons), P Grad Dip. Mfg Tech, MBA
T: +353 86 323 6131
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Bernadette O’Brien is a Senior Consultant and Qualified Person at EUPS with over 20 years’ experience in the Pharma and Biopharma industry. Bernadette has an Honours Degree in Pharmacology and a Master Degree in Business Administration. She held a number of senior quality leadership roles before being appointed as Head of Quality with responsibility for Quality Assurance, Compliance, Quality Control Chemistry, Microbiology, Regulatory Affairs and Validation. She has worked at IVAX, Teva, Genzyme and Sanofi with both clinical and commercial products, across aseptic filling, oral dose and inhalation platforms. Bernadette has extensive experience in hosting inspections with HPRA and US FDA, in addition to experience with Regulatory Inspections by CFDA, Canada, Russia, Korean, Turkey, Brazil, Japan and GCC. With expertise in Quality Systems and Operational Quality Compliance, Bernadette has a proven capability in Technical and Analytical Transfer, Product Life Cycle Management, Quality Risk Management and Human Error.
Martin Kierans BSc (Hons), MSc
T: +353 87 951 0103
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Martin Kierans is a senior pharmaceutical professional with over 20 years of experience in Quality Assurance, Quality Control and Quality Systems. Martin has a broad range of international experience across the pharmaceutical supply chain. He has technical expertise and hands-on experience of quality management systems for: in-house and third party manufacturing, packaging and analysis; affiliates and MAH activities including pharmacovigilance, sales & marketing and GDP. Martin earned his Msc degree in Instrumental Analytical Chemistry from Anglia Polytechnic University, Cambridge UK, his BSc (Hons) degree in Analytical Chemistry with Quality Assurance from Cork Regional Technical College and his Postgraduate Diploma in Pharmaceutical Manufacturing Technology from Trinity College Dublin. He is an eligible QP since 2009.
Mary Wallace BSc (Hons), MSc
T: +353 87 261 5692
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Mary Wallace has been a Senior Consultant at EUPS since November 2014. She obtained QP status in 1986, and has had over 30 years experience of QP release, QMS and regulatory requirements in the pharmaceutical industry. Her experience has been gained over a wide range of medicinal products including solid dose pharmaceuticals, sterile medicinal products, parenteral nutrition and API production. Mary was instrumental in setting up and establishing the Diploma in Pharmaceutical Manufacturing Technology (QP course) in the School of Pharmacy, TCD. She was the Course Co-ordinator for 10 years. Before leaving TCD in 2000, she introduced and set up the first QP Forum in 1999. Mary has a B.Sc. (Hons) in Chemistry and Maths and an M.Sc. in Phytochemistry from UCD. In the past Mary has worked for Birex Pharmaceuticals, B Braun, LEO Laboratories, Mallinckrodt Medical, Newport Pharmaceuticals, Niche Generics, Pharmafile, Pharmapac, Servier and Warner-Lambert.
Patrick Brougham MSc
T: +353 86 172 4136
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Patrick (Paddy) Brougham is a Senior Consultant at EUPS. Paddy is a pharmaceutical executive with excess of 35 years’ experience working in the Pharmaceutical Industry. Initially working in the manufacturing of Active Pharmaceutical Ingredients (API) where he held many senior positions in Quality Control, Quality Assurance and as overall Head of the Quality and Regulatory function in Schwarz Pharma (previously SIFA Ltd).). He subsequently moved into Pharmaceutical manufacture and production including product transfers from Germany to Ireland of pharmaceutical dosage forms (Oral tablets both immediate and slow release). He also acted as QP (Qualified Person) in this role. Later having joined Cambrex Cork as head up the Quality Function, he assumed an international role in the overall expansion of the Organisation. In 2005, he joined McKesson Corporation to set up and lead their private label project “NorthStar”. This involved identifying Generic sources of finished dosage products in Asia and assisting, developing and managing the subsequent sale of these product in the US. Paddy has a wide range of experience in all areas of Pharmaceutical Manufacture, Quality Control, Quality Assurance, Laboratory Information Management Systems and Regulatory Affairs. He also has extensive experience in Supply Chain Management and evaluation of all pharmaceutical suppliers for the regulated markets. This experience covers all dosage forms including Oral solids, liquids and suspensions, as well as experience on injectable dosage forms both thermally sterilised and aseptically filled.
Paddy has B.Sc. Honours Degree in Chemistry and an M.Sc. Degree in Pharmacology. He is also a certified Quality Auditor and Trainer.
David Cazabon BSc, MSc (Biotech), H.Dip.Pharm.Man.Tech.
T: +353 87 289 0663
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David Cazabon is Senior Consultant with The Compliance Group. After qualifying as a Microbiologist and Biotechnologist, David has spent twenty three years working in the pharmaceutical and medical device industry in Microbiology, Sterility Assurance and Quality Assurance (QP). In his capacity as a Director with Baxter Healthcare, he had responsibility for all aspects of sterility assurance and microbiology including moist heat, gamma, ETO/Gas sterilisation, sterile filtration, contamination control strategy, microbial contamination investigations, microbial/sterility risk assessment, microbiological testing, product transfers, training, and management of regulatory change for all facilities in Europe, Middle East, and Africa.
Ann Ballesty BSc (Hons), MBA
T: +353 86 404 1777
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Ann is a quality professional with more than 25 years of management experience in Pharmaceutical, Medical Device and Cosmetic manufacturing. Roles to date have included responsibility for site Quality assurance, compliance, quality control, regulatory affairs, new product introduction, process transfer and scale up and validation. She has also worked in international corporate roles in the supply-chain management (due diligence auditing, GxP auditing and contractor oversight) for both clinical and commercial pharmaceutical manufacture and medical devices. She has participated in teams which have successfully passed their first GMP & GDP license applications and NDA inspections. As part of continuous improvement Ann has been involved in working on improved technical writing skills and human error reduction programs.
Product types and processes with which she is familiar include small molecule APIs, bulk drug substances, medical devices and finished pharmaceuticals and biopharmaceuticals. Dosage forms include lyophilized products, aseptic filling, liquids & tablets, creams, sachets, powders and patches.
Andrew Barrett MPSI, MRPharmS
T: +353 87 249 1370
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After initially qualifying in the area of Quality Assurance, Andrew worked in the pharmaceutical industry in several Quality roles. Andrew continued his education to qualify as a pharmacist. His interest in the Quality area has resulted in taking up roles as a Responsible person for many companies. Clients have included small to medium size business all the way up to Multinationals looking for an expert in the GDP area. More recentl Andrew has acted as a consultant in the growing area of virtual wholesaling. Currently Andrew acts as Supervising Pharmacist in his own Pharmacy business.