T: +353 87 231 0186
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Mark McComish, BA (Acc), FCA
Mark 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.
T: +353 86 603 2297
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Stan O’Neill BSc (Pharm), MPSI
Stan 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.
T: +353 86 323 6131
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Bernadette O’Brien BSc (Hons), P Grad Dip. Mfg Tech, MBA
Bernadette is a Senior Consultant and Qualified Person at Compliance Management (formerly 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.
T: +353 87 951 0103
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Martin Kierans BSc (Hons), MSc
Martin 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.
T: +353 87 261 5692
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Mary Wallace BSc (Hons), MSc
Mary has been a Senior Consultant at Compliance Management (formerly 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.
T: +353 87 289 0663
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David Cazabon BSc, MSc (Biotech), H.Dip.Pharm.Man.Tech.
David 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.
T: +353 86 404 1777
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Ann Ballesty BSc (Hons), MBA
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.
T: +353 87 249 1370
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Andrew Barrett MPSI, MRPharmS
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.
T: +20 100 860 8123
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Ehab Nofal, BSc, MBA
Ehab is a pharmaceutical manufacturing professional with more than 17 years of management experience in Pharmaceutical manufacturing. Roles to date have included responsibility for site Quality assurance, compliance, quality control, regulatory compliance, new product development, process transfer, scale up and validation.
He has also worked in due diligence auditing, GxP auditing and contractor oversight for commercial pharmaceutical manufacture. Successful track record in leading compliant operations with a deep understanding of what it takes to run a compliant organisation. Significant exposure to numerous internal and external audits for pharmaceutical manufacturing sites. Demonstrated application of quality understanding in the manufacture of pharmaceutical products within multiple organisations. Strong technical knowledge of all Pharmaceutical Operations.
Quality systems building & implementation, GxP compliance, Project management, Product improvement, Product preparation for launching, Quality auditing, CAPA, Regulatory Affairs, Production management, pharmaceutical processing, Leadership, CMOs auditing and ratings.
T: +44 76 94033 698
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Arvind Vijayabhaskar, BPharm MSc(Dist.) MSc (Oxon)
Arvind has worked in the pharmaceutical industry for over 23 years. Arvind has an MSc degree in Experimental Therapeutics, MSc degree in Industrial Pharmaceutical Sciences, and a bachelor’s degree in Pharmacy. He has been a UK Qualified Person since 2011, Chartered Chemist, Chartered Scientist and Responsible Person. Arvind’s work experience includes manufacturing facilities, virtual, third party contract manufacturing and matrix organisations.
Proven capability in manufacturing and quality assurance as a QP, working across product lines such as tablets, capsules, MDI inhalers, ointments, creams, gels, liquid sprays, aerosols, and nasal sprays, sterile drug device combination product and Biosimilars. Quality Expert review of CMC regulatory submissions for various process changes and ensured MA compliance for new Product launch for EU, US, and Canada markets. Audited the multiple API, finished product, contract QC lab and storage/ distribution sites, and involved in quality remediation / inspection readiness projects. Hosted and participated in the multiple MHRA audits, USFDA audit and BSI audit for medical devices.
Routinely prepares and delivers training programs on the topics related to UK QP study guide modules and regular tutor for the Qualified person PG Diploma programme at UCL school of Pharmacy, London.
T: +353 87 4191561
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Lorna Loughrey, BA(hons) Natural Science – Pg. Dip Pharmaceutical Manufacturing Technology
Lorna is a pharmaceutical professional , Microbiologist, Quality Control and Quality Assurance Specialist and Qualified Person for more than 30 years. Experience in the manufacture of a variety of medicinal products; sterile products including biologics and radiopharmaceuticals; non-sterile products including tablets, creams and lotions.
Currently Coordinator for the QP course in School of Pharmacy and Pharmaceutical Sciences in TCD.
T: +353 87 9344449
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Orla Campbell, MSc, BSc(Hons), MRSC
Orla joined as a Senior Consultant at Compliance Management (formerly eups) in 2019. She has a diverse range of experience from Development, Clinical Trial/IMP, Manufacturing, Validation, CQV, pharmacovigilance, QMS and Regulatory as well as hosting HPRA and FDA inspections for new products and experience in GMP, GDP and Pharmacovigilance audits.
She obtained QP status in 2004 , and has had 15 years’ experience of QP and IMP/IND certification over a wide range of medicinal products including solid dose pharmaceuticals, Inhalation products, sterile medicinal products and various Combination products.
She held a number of senior Quality and Leadership roles responsible for Manufacturing Site builds, Quality Assurance, QMS Design, development and Improvement projects, CQV and Process Validation Device Design, Medical Devices, Quality Control, Method Development and Transfer and Contract Manufacturing operations including auditing to GMP. GDP, CFR 820, ISO 13485 and CFR Part 4
T: +353 87 9895355
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Gemma Lawlor, BPharm, MPharm, MPSI
Gemma is a qualified Pharmacist having qualified with a BPharm from UCC followed by an MPharm from RCSI. She has worked both in community pharmacy and also in the pharmaceutical industry. Gemma has worked as both a Qualified Person and Quality Manager in several companies, ranging from startups to multinationals.
Gemma has gained experience releasing a variety of medicinal products, which include sterile medicinal products, chemotherapy products, antibiotic products, parenteral nutrition, gels, creams, ointments, and solid dose products. Gemma has experience in both setting up and managing/maintaining Quality Management Systems. She is also a trained auditor. Gemma is a qualified life and business coach and is lead coach in her own coaching business.
T: +353 86 0496907
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Stephanie Butler, BSC (Hons), MSC
Stephanie is a pharmaceutical professional and Qualified Person with over 20 years’ experience in the Pharma and Biopharma industry. She has a BSc in Biotechnology from DCU, an MSc (Ag) from UCD and Postgraduate Diploma in Pharmaceutical Manufacturing Technology from TCD. She is an eligible QP since 2009. Stephanie also has a certificate in Software Engineering, has qualified as PMP and trained in GMP auditing, QRM facilitation and lean/six sigma. She has worked in Jazz Pharma, Pfizer, Wyeth, Icon Clinical Research and Warner Lambert in various Quality roles including QP (commercial and IMP), QA Operations, Quality Systems, QC Chemistry and Project Management.
Stephanie has hands on experience across a wide range of medicinal products including small molecule/biologics, API/DS/DP and FP, steriles liquid and lyophilised, solid oral dose liquid and tablet/capsules. Stephanie’s experience is across the product lifecycle from qualification, manufacturing, testing, packaging and distribution, both internal and CMO manufacturing. She has participated in several HPRA and FDA inspections including preparation for pre-approval inspections. Also experienced in review of CMC regulatory submissions (BLA, NDA, IMPD), due diligence auditing and new supplier qualification.