Our Team

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.

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.

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.

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.

Francis is an experienced pharmaceutical operations leader with over 35 years of experience with a proven track record of delivering major projects, including people change management. He is an  effective communicator with a strong technical background.

During his career Francis was responsible for an OSD manufacturing network supporting $4B revenue,
managing 1000 employees. Francis delivered on-time commercialisation of multiple NPIs, including 6 NDA/PAI approvals in 3 years. He also led the design, development and deployment of a “paperless QC laboratory” for batch release and stability.

Francis’ experience as a Site General Manager includes turnaround and recovery, managing through several mergers and acquisitions, and strategic site development. He believes the clear articulation of a site’s strategic value to the company is fundamental to its continued development. He is familiar in dealing with state agencies.

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. 

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.

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

Pierre bio to follow