I am a married man living in Oxfordshire. I obtained my pharmacy degree from Bath University in mid-80s with did my pre-registration training at the Oxford teaching hospitals. I have worked in the UK pharmaceutical industry for 23 years in a variety of technical/operational positions with responsibility for production, QA, QC, regulatory, validation and general management. I have worked with a variety of dosage forms-tablets/ capsules, liquids/creams, small volume aseptic products, biologics, blood products and clinical trial manufacture.
I have been a QP assessor for five years, which involves assessing prospective QP candidates with assessors from the other professional bodies through the application form and viva process.
Why did you decide to become a QP?
Working in a pharmaceutical production environment is something I have enjoyed. Being a QP provides me with an opportunity to work with many different functions – production, QA, QC, validation, engineering, logistics, marketing, safety, medical. My job requires me to make challenging decisions balancing patient safety, GMP, legal considerations.
I wanted a recognised qualification in pharmaceutical operations and feel that training to become a QP is an excellent foundation for any leadership role in pharmaceutical operations.
Whilst in the UK, the pharmaceutical production sector is not increasing, the need for QPs will continue as a product needs to be QP released into the EU.
How did you achieve QP eligibility status?
Via the permanent provisions (category A) in the late 1990s.
How did you prepare for your viva?
Being a pharmacist, I had already learned much of the QP study guide knowledge requirements. Combined with 10-plus years of practical experience, I only needed to attend three knowledge modules from a training provider.
This was agreed between my company sponsor, David Begg Associates (DBA) and myself after a detailed discussion on my education and experience against the QP study guide. From a practical experience viewpoint, I agreed with my sponsor some additional practical laboratory and laboratory management experience.
I had a number of practice vivas with my sponsor and with DBA.
As a pharmacist in pharmaceutical operations, becoming a QP can be an easier path than for chemists and biologists.
What is your current job?
As a Qualified Person, I have had responsibility for QA and product release in classical aseptic products, blood products and biologics.
I now work for Allergan UK based in Marlow. My company manufactures and sells botulinum toxin, ophthalmology products and a range of medical devices. I am responsible for quality for commercial distributed product in the European region.
Being a QP helps me when working with quality colleagues in our manufacturing plants in Europe and in the US.
I am named as a Qualified Person on our clinical trial manufacturing licence for the Marlow site. Aside from product release activities, I am involved in audits of manufacturing sites for GMP compliance and a wide range of Quality Management activities. I also have responsibility for regulatory for medical devices and some pharmaceutical markets.
How has this added to your personal development? Was it worth it?
Being a Qualified Person is a natural step for a pharmacist working in the industry. The training and “permanent provisions” QP eligibility is well understood within the industry and recognises you as someone who has a strong knowledge and experience in pharmaceutical quality. Qualified Persons are often in short supply and job opportunities for QPs are good and can be well paid. The QP experience is a good step towards further development within senior management in a company.
Would you recommend this career option to other pharmacists, and why?
Definitely. As a pharmacist, it uses and develops the knowledge we gain from a pharmacy degree. Patient safety is fundamental to the QP role. The role is very varied, challenging and an excellent career path for pharmacists.