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Detailed Management Committee Page
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Welcome to the Management Committee Page

Here you will find more details on the management committee, contact information and a short biography.

 

James Drinkwater

Position: Chairman

Email: jamesdrinkwater@phss.co.uk

Biography: 

James Drinkwater is the Head of Aseptic processing technologies and GMP compliance at F Ziel Germany. James has the role as Chairman of the and leader of the PHSS Bio-contamination and RABS special interest groups. James is also an active member of the PDA and ISPE.

Having worked 10 years in the Pharmaceutical industry, Amersham UK now GE Healthcare this was followed by positions of Technical Director at Barrier technology companies and Process and Compliance Director at a Bio-decontamination company. James is a subject matter expert (SME) on Gaseous disinfection and surface sterilisation using Hydrogen peroxide vapour (VH202) technologies together with associated biological indicators with contribution to the PDA technical report 51 on BIs for gaseous decontamination processes.

James current specialisation is in the area Aseptic processing for sterile product manufacturing, filling and sterility testing, working actively on projects providing support in process design, control strategies, risk based process monitoring for solutions in contamination and cross contamination control together with GMP compliance.

 

Jenni Tranter

Position: Vice Chairperson

Email: jenni.tranter@synergyhealthplc.com

Biography:

Jenni joined the Management Committee of PHSS in November 2013, bringing 20 years’ experience working in Healthcare and Medical Industries and became Vice Chair of PHSS in July 2015. Jenni graduated from UWIC in 1998 with BA(Hons) in Business Management and worked for Healthcare manufacturers prior to joining STERIS AST in May 2003, as a Regional Sales Manager, then in 2009 became Marketing Communications Manager, transitioning to Business Development Manager in 2013 before moving into her current role in 2016.  In her role as Senior Marketing Manager,  Jenni is responsible for all Marketing activity conducted within the EMEAA region. This involves engaging with colleagues and Customers across the whole of the region. My role is very diverse, involved in many projects ranging from Market segmentation/development strategies, Pricing and Contract Management, Competitor surveillance, Event & CRM Management to Brand values and Employee engagement initiatives. Commenting on how her involvement with PHSS supports this aspect of her professional role Jenni said: “PHSS brings together the health care and life sciences sectors and offers a vast range of knowledge and expertise. “My PHSS membership and involvement support the training packages we provide, ensuring they are of educational benefit. Highlighting this Jenni said: “The PHSS attracts the best thought leadership and opinion influencers in our industry. Emphasising the not-for-profit status of the Society Jenni said: “The PHSS’ focus is entirely on its members, delivering, practical guidance to support its membership. The membership fee is incredibly good value given the resources, information, events and networking opportunities that PHSS provides. “PHSS is the go-to Society for assistance with the challenges associated with regulatory change and manufacturing - without trying to sell you anything.”

 

Janice Wallace

Treasurer

Email: janice.wallace@pharmagraph.co.uk

Biography:

Janice joined Pharmagraph in 2011 as an Applications Engineer after working as a project engineer for 5 years within the same industry sector. Her role within Pharmagraph involves working with customers on assessing and delivering particle and environmental monitoring systems for monitoring cleanrooms and controlled environments mainly in the pharma, aviation, space and life science industries.

Janice was on the working party for the PHSS Special Interest Group which produced the published guide to continuous particle monitoring to EU GMP Annex 1 from the PHSS ‘Best Practice for Particle Monitoring in Pharmaceutical Facilities’.

Janice is a member of the Institute of Engineering and Technology (IET) and PHSS. Janice has been on the IET Hereford & Worcester Management Committee since 2012 and on the PHSS Management Committee since 2008. She has actively contributed to the Society. Assisting with organising events, speakers and contributing to the Special Interest Group on Particle Monitoring, as well as regular attendance at Management Committee meetings.

 

Adam Bird

MC Member

Email:  adambird@phss.co.uk

Biography:

Mr Adam Bird has more than 17 years' technical and quality experience in the pharmaceutical industry, the majority of which were spent in microbiological quality control roles with GSK, Pfizer, Abbot, BUPA, Hospira, Boehringer Ingelheim, Orbis Consumer Products and now Oxford BioMedica; where he has been for the last 7 years and his role has transitioned significantly more into ATMP Quality Assurance. This QC/QA experience spans many dosage forms including oral solid/liquid dose, topicals, aseptic fill, freeze dried and terminally sterilised products, dry powder fills, aseptic compounding, blow/fill/seal, and now clinical and commercial gene/cell therapy products with Oxford BioMedica. During his time at Oxford BioMedica he has also played a primary role in the design, commissioning and licensing of two new state of the art manufacturing facilities.

He has a Post Graduate Diploma in Industrial Pharmaceutical Studies from the University of Brighton, and is preparing his application to the Royal Society of Biology for Qualified Person eligibility; having studied and gained practical experience across all aspects of the QP Study Guide. Adam is a member of the Royal Society of Biology and has been a member of the PHSS for approximately 9 years. 
Adam was co-author on the George Sykes memorial prize winning paper in the EJPPS 2010 "Contamination of cleanrooms by people", and was a significant contributor to the PHSS Technical Monograph 20 "Biocontamination". He also presented material at the PHSS annual conferences in 2014 and 2016. 

 

Matt Cokely - co-opted member

MC Member

Email: Matthew.Cokely@ecolab.com

Biography:

Matt Cokely has more than ten years’ experience within the Pharmaceutical Industry as a Pharmaceutical Microbiologist. He has experience of working in graded cleanrooms and in the manufacture of a range of pharmaceutical formats including solid oral dosage units, oral liquids, powders and sterile injectable products.

From June 2001 to August 2007 Matt was the Section Head of Microbiology for an international pharmaceutical manufacturer, managing two busy microbiology laboratories serving two manufacturing plants. (One FDA/MCA approved tablet manufacturing facility and one MCA approved soft gelatin capsule manufacturing facility for H&N/OTC/pharmaceutical products). Matt worked alongside colleagues and contract customers nationally and internationally, participating with them in product development, manufacture for clinical trials, cleaning and method validation, and participated in supplier audits.

Matt has worked for Ecolab for over nine years, and is currently a Global Validation Manager for ECOLAB Contamination Control division. This is a technical role advising on correct application and use of specialist cleanroom biocides and cleaning equipment for Life Science Cleanrooms in line with current regulatory guidance and Industry Best practice. His extensive microbiological experience and knowledge has enabled him to support numerous customers through the validation and implementation process of cleanroom disinfectants. In his role as Global Validation Manager, Matt also presents on a number of contamination control topics at various industry seminars across the world. He also recently successfully completed an IRCA Pharmaceutical Quality Management Systems auditor/lead auditor training course, and is in the process of registering as an IRCA certified auditor.

 

Lindsay Dick

MC Member

Email: lindsaydick@phss.co.uk

Biography: 

Dr Lindsay Dick is currently Head of Production for Cancer Research UK Formulation Unit based at the University of Strathclyde. She has more than 15 years of pharmaceutical industry experience initially specializing in drug formulation. For the last 10 years she has concentrated on the manufacture of both sterile and non sterile dosage forms for Phase I and II clinical trials.

Dr Lindsay Dick has been a Member of the PHSS for 6 years. She qualified as a pharmacist from University of Strathclyde, which was followed by a PhD in Pharmaceutics also from the University of Strathclyde. She is a member of a number of scientific professional bodies including the Royal Pharmaceutical Society of Great Britain and the General Pharmaceutical Council.

 

Alan Heavey

MC Member

Email: alan@sterilizationsolutions.co.uk

Biography:

 

Alan is a Consultant Sterilizing Engineer registered by the Institute of Healthcare Engineering and Estate Management (IHEEM), originally as an Authorised Person (Sterilizers) and now as an Authorising Engineer (Decontamination).  He has over 35 years of ‘hands-on ‘experience in the field of steam and dry heat sterilization as a consultant and trainer within the Pharmaceutical, Biotechnology and the Medical Device industry.  Alan operates internationally and constantly seeks to ensure an understanding of good science and ‘sound reasoning’ as a basis to meeting GMP to ensure a quality product, in an area of increasing regulatory concern.

 

 

Malcolm Holmes

MC Member and author of Monthly Regulatory Update

Email: malcolmbrian.holmes@tiscali.co.uk

Biography:

 

Malcolm is a Chartered Chemist, a Member of the Royal Society of Chemistry and eligible as a UK Qualified Persons Register. He joined the management committee of PHSS in November 2013 and is the author of monthly and quarterly Regulatory Updates for members and a contributor to the biocontamination monograph. He is also a member of International Society for Pharmaceutical Engineering (ISPE) and was a co-author of the ISPE RiskMaPP (ISPE Committee of the year award 2010). As well as these activities, Malcolm is also a member of the Advisory Panel of the magazine GMP Review.

He has international experience having worked for GSK in Iran, Italy, New Zealand, and Spain over a period of more than 10 years. He spent many years in senior positions in the GSK Corporate Quality Directorate, during which time he was an active member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing and GMP Committee, leading the EFPIA Topic Teams for Mutual Recognition Agreements / Regulatory Inspections /ICH Q9 (Quality Risk Management) for which he received a USFDA “Levering Collaboration Award 2011”

Since retirement after 41 years with Glaxosmithkline, Malcolm maintains an active interest in the pharmaceutical industry and its regulation. He provides ad hoc consultancy and training within the industry and professional bodies and is a part time lecturer to the Faculty of Pharmacy at Brighton University (UK) to Post graduate QP students.  He has had extensive exposure to the Global aspects of the business and the changing global regulatory climate.

 

Tammy Hassel

MC Member

Email: tammy.hassel@microgenetics.co.uk

Biography:

 

Ms Tammy Hassel is a qualified Microbiologist and MBA, bringing a unique mix of skills and perspective. She has over 12 years’ experience working within Quality in the pharmaceutical manufacturing sector. Tammy has worked at both sterile manufacturing and compounding sites, in senior Quality Assurance roles overseeing Quality and Compliance and has been responsible for the successful validation of a new aseptic manufacturing facility and custom built rapid gassing facility. She is now heading up a microbiological services business with the aim of bringing innovative microbiological solutions to the pharmaceutical manufacturing sector.  Tammy is looking to join the PHSS management board as she is passionate about microbiology and quality and would like the opportunity to give back to the wider sector.

 

 

Julian Kay

MC Member

Email: juliankay@phss.co.uk

Biography:

 

Julian  is currently Director , Sterile Processing and Microbiology, Quality  for the Sterile and Biopharm Supply Chain at GSK.  This role is accountable for the generation, maintenance and deployment of the company sterile standards encompassing system, process, facility, equipment and testing elements.  He is also accountable for maintaining the Sterility Assurance network in the Pharma supply chain which is tasked with providing support and direction across the manufacturing sites and product portfolio. Prior to this role, Julian has held a number of  senior centrally based roles at GSK spanning almost 20 years,  leading technical elements of sterile processing and has significant experience in facility assessment, incident support and leadership, technical standard development, and audit ( inspection and hosting) . He has also led site quality operations for sterile manufacture.  Specific external activities to highlight include presentations given at PDA, Pharmig over the years ranging from validation and aseptic standards for ATMPs, non sterile microbiological control, rolling out the PDA points to consider. Interaction with authorities include multiple engagement with FDA either in Bethesda on subjects such as disinfectant validation, RABS design or through site audits with FDA,  MHRA and other authorities in the capacity of Sterile SME . Julian is also on the 2019 organising committee for the Kilmer conference representing the pharma industry.

Julian would like to be considered for the PHSS management committee as he believes he can make a contribution to the advocacy efforts of this organisation both within industry and the regulators.  He has a large internal network at GSK to help garner support for evolving standards and positions with respect to sterile manufacturing.

 

Di Morris

MC Member

Email: dimorris@phss.co.uk

Biography:

 

Di Morris  - MRSC Chemistry and PGDiPS and a Qualified Person under permanent provisions since 1993; who has worked in the pharmaceutical industry for over 30 years, a number of years as a Medicines Inspector for the MHRA. Di has worked in the areas of Quality Control (Chemistry and Microbiology), Quality Assurance and Regulatory Affairs and worked with a wide range of dosage forms including sterile products, biological, and non-sterile products. Di now works for GSK in the Compliance Audit Group.

 

Colin Newbould

MC Member

Email: colinnewbould@phss.co.uk

Biography:

 

Mr Colin Newbould is an experienced Qualified Person and Executive Quality Professional, leader of global quality teams, change agent and previously a member of the Pharmaceutical Quality Group.

He is experienced in successfully developing and implementing strategy to ensure world class compliance, effective processes and customer satisfaction. Experience in facility design and startup and extensive experience in managing supply chain quality, risk management, driving change and continuous improvement. 

His area of experience covers the majority of pharmaceutical dosage forms, modified release, controlled drugs, herbal medicines, excipients, emolients, APIs, laboratories, cold chain, unlicensed medicines and specials.

Colin has extensive experience with competent authorities including MHRA, TMoH, ANVISA & FDA.

 

Kay O'Hagan

MC Member and Editor in Chief

Email:  kayohagan@phss.co.uk

Biography:

Kay joined the Parenteral Society in the early 1990s and has served on the PHSS committee for almost a decade. Her professional responsibilities in Quality Control for Hospira make her involvement with PHSS crucial to her success and that of her organisation.

Explaining the value of her PHSS membership Kay said: “It’s the best way for me to keep up-to-date with best practice regulations and changes.

“Thanks to the admirable energy and drive of our Chairman James Drinkwater the technical monographs have been given a new lease of life. These are critical documents in sharing knowledge and expertise within our industry and the PHSS is the only place where they can be found.”

A major benefit of PHSS in Kay’s eyes is the networking opportunity it provides.

“This was especially important when I started work in Wales for PCI,” Kay said. “There were lots of small science-based and bio-tech companies based in the region, but there were no opportunities locally for Continued Professional Development. Qualified Persons need to make a register of  their CPD available to the MHRA , but industry professionals had to take themselves to London for events, which was proving time-consuming, costly and ineffective.”

So under the PHSS Special Interest Group umbrella Kay established the Welsh Qualified Persons’ Forum.  “Initially we organised quarterly meetings but this has now become an annual conference,” Kay said.

“It is a small and productive gathering. Focussing on local companies it is an excellent network for the Welsh pharmaceutical industry, which the Welsh Government is keen to promote.

“As a result opportunities have arisen for greater association with Welsh universities to offer courses in pharmaceutical GMP, bringing local companies closer to the academic R & D community.”

Commenting on the importance of conferences in the PHSS calendar Kay said: “They make it easy to meet people outside work with the same issues as you are dealing with. You can discuss concepts and approaches and different ways of doing things. It gives you confidence to know that you’re doing things properly; and guidance when you need to know how to tackle issues.

Talking of the significance of the PHSS Kay said: “It is very important to me and to the UK pharmaceutical industry that the Society continues to prosper and deliver the range of services currently offered.

“There’s no other way to get non-biased, objective, up-to-date information and guidance in our profession.”

 

Andrew Stevenson

Co-opted MC Member

Email: Andrew.S@Bpe-ds.com

Biography:

 

Mr Andrew Stevenson is a Chartered Biochemical Engineer with 25 years Industrial experience working in the areas of aseptic process design and technical support. He is currently the Technology Director at BPE; a specialist engineering consultancy focussed on the process industries. Previously worked in Engineering Management roles in the UK & Ireland for companies including CSL, Novartis Vaccines, Pfizer Biotech, Amgen and Celltech Biologics. His experience covers all aspects of Biopharm manufacturing operations including Utilities, Drug Substance and Drug product facilities with a focus on facility & process design and technology transfers between different sites.

 

 

Graham Steele

MC Member

Email: graham.steele@tesco.net

Graham is an experienced microbiologist. From 2002 – 2008 he was based at Albert Browne Ltd. (a subsidiary of  Steris UK), where he was employed as a Consultant Microbiologist working on the development of biological indicators displaying high standards of reproducibility for use in sporicidal vapour-phase decontamination cycles and a range of sterilization processes.  He was Head of the Department of Biomedical Sciences at the University of Luton (now University of Bedfordshire) until 2002, when he left to develop his role as an independent consultant to the pharmaceutical and medical device manufacturing industries in the areas of sterilization and contamination control. Having over 35 years’ experience in higher education, lecturing on a wide range of subjects in the field of microbiology. 

Graham has been involved in British Standards Institute Subcommittees and involved in working parties for Technical Report Publications. 

Graham has been on the Management Committee since 2008 and has contributed to the Society.

 

Pam Turner

Co-opted MC Member

Email: pam@geryonpharma.com

 



 

 
 
 
 
 
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