About · Credentials and how I work
A practising microbiologist who builds quality systems.
I am Tamryn Hassel, a pharmaceutical microbiologist and quality specialist, and the founder of Mozeka.
I have worked in pharmaceutical quality for around 21 years, across quality assurance, quality control and microbiology: sterile and non-sterile manufacturing, compounding, cell and gene therapy and other ATMPs, stem cell facilities, contract laboratories, suppliers and R&D. I have worked at the bench, run QC microbiology for a global biologics CDMO, set up the QC laboratories for a new cell therapy manufacturing site, and managed quality teams.
I started Mozeka in 2021 so that start-ups and small businesses with limited resources could have that experience without the headcount.
Tamryn Hassel · Founder, Mozeka Limited
Why Mozeka exists
Start-ups shouldn’t have to reinvent the wheel.
Every new pharmaceutical company builds the same foundations: a quality manual, change control, deviations, a contamination control strategy, a way of proving it all works.
Most build them from a blank page, with a small team that has never done it before, against a licence date that does not move. Months go on writing what already exists somewhere, while the work only that team can do waits.
I started Mozeka in 2021 to give them a head start: proven documents, a method that works, and people who have built it before. The system runs sooner, and their people spend their time on the science, the product and the patients it is for.
I would rather you understood your quality system than simply complied with it. So everything I build comes with the reasoning behind it, and your team keeps that knowledge long after I have gone.
What the work pays for
Part of what Mozeka earns funds Khula Pathways, an education programme for children in KuGompo, South Africa, where I grew up. It began nine years ago with one child’s schooling.
Registrations and qualifications
The register
What I hold, stated plainly, so you can check it before you call.
Practising pharmaceutical microbiologist
BSc Zoology and Microbiology. Still practising: not a former microbiologist who now manages.
GMP Lead Auditor, MHRA-facing
Supplier, contractor and self-inspection audits to UK and EU GMP, and GDP audits for distributors.
Responsible Person
Named RP on UK wholesale dealer’s licences, available on a contract basis.
MBA
The commercial side of running quality: budgets, people and the decisions that sit above the system.
Published research
Agar desiccation and its effect on environmental monitoring, in the European Journal of Parenteral and Pharmaceutical Sciences.
Tutor
Teaches pharmaceutical microbiology to aspiring QPs and quality professionals.
I am not a Qualified Person.
QP is a separate registration I do not hold. If your work needs a QP to certify batches, you will need somebody else for that part, and I will tell you at the start rather than on the third call.
Quality systems designed, built and handed over.
A quality control laboratory, cell and gene therapy manufacture, and licensed manufacturing. All still running, each one now run by the client’s own team.
The method
Design, write, check. With your part named at every stage.
A quality system only works if the people who run it helped build it. So every stage says what I do and what you are responsible for.
Design
Scope, risk rationale and decision rights. What the system has to do, and who decides what.
Give me access to how you really work, and the people who actually do it.
Write
Procedures, records and the controls around them, sized for your stage.
Review and approve within the agreed dates. This is where projects slip.
Check
Internal audit, readiness review and evidence an inspector can follow.
Name one person who owns the system after handover.
Associates and review
You always know whose name is on the work.
Audits and some advisory work are delivered by named associates. I hold the client relationship, choose who does the work and review every report before it is issued. You are told who carried out your audit.
Cover
If I am unavailable, the work is not.
Named cover from the associate bench, with the engagement documented well enough that somebody else can pick it up. You are told before it happens, not after.
Commercial facts
The details your procurement team will ask for
Everything here can be checked before you contract.
Mozeka Limited, company 15336551, registered in England and Wales. You contract with the company, never with me personally.
Public liability, employer’s liability and professional indemnity. Certificates available on request before contracting.
Nothing about how a client operates is published without their written approval. Not in a case study, not in a talk, not as an aside.
29 Bridgford Road, West Bridgford, Nottingham NG2 6AU
hello@mozeka.co.uk · 0207 099 7768