What does a typical day in your job involve?
You might be wondering what is a trainee Qualified Person (QP)? As a trainee QP I am working toward becoming eligible to act as a QP, the person who assumes responsibility for certifying that batches of pharmaceutical product have been manufactured in accordance with its marketing authorisation. The QP is therefore in the unique position acting as quality assurance on behalf of the patient to assure the quality, safety and efficacy of medicines.
The day to day tasks are variable and could involve reviewing manufacturing, analytical or quality management records in order to enable a decisions to be made on batch release, attending teleconferences or meetings with clients answering QP related questions, or being involved in quality investigations. A lot of time is spent interacting with the various departments throughout the business and also with our external clients to ensure that the regulatory and quality controls are in place to allow the release of product in accordance with project timelines. Other days could be spent representing the quality department on customer audits or regulatory inspections, acting as the auditing body of 3rd party manufacturers and suppliers or working on business improvement initiatives.
What type of other skills do you need for your job, other than educational qualifications?
To fulfil the role you need to be a good communicator with an attention for detail and an ability to analyse, extract and absorb a lot of technical information in order to make confident judgements that balance the potential business, regulatory and most importantly patient risks. Good leadership and people skills are ideal as often you often have to extract information from others or deliver unfavourable news where it is important your judgement is accepted. The role requires the ability organise and prioritise tasks reacting to immediate issues whilst maintaining an oversight of activity within the quality system. A thorough understanding of the pharmaceutical industry is required including specific knowledges of the manufacturing processes for the products you’re are certifying.
There are also number of roles within quality that support the responsibilities of the QP and are vital to ensure that product quality measures are in place and adhered to providing a great opportunity to build interpersonal skills and experience of the pharmaceutical industry.
What do you love most about your job?
I love being challenged and the job presents plenty of opportunity for applying problem solving skills and using creative thinking whilst not compromising on quality. I have always been interested in how things are made and this lead to my interest in science and being able work in a job that combines the two interests is ideal. I also enjoy learning new things and as the pharmaceutical industry is constantly evolving there is plenty of opportunity for development. There are a lot of experienced personnel within Almac providing the opportunity to learn from their expertise and it is this quality of the people that contributes to making Almac a great environment to work in. Ultimately knowing that the work I do directly contributes to delivering high quality medicines to improve the lives of patients throughout the world is something worth getting up for.
What great opportunities have you had in your role?
Working within the quality department I have taken advantage of a number of opportunities available within the business, the most significant of which was a 2 year secondment to our new Charnwood facility in England where I was part of the project team tasked with the setup of the site. I had the responsibility of implementing a quality system and was actively involved in the commissioning and validation of facilities, utilities, computerised systems and equipment. The experience gained will be invaluable to a successful career in the pharmaceutical industry and seeing the facility through its first MHRA regulatory approval was a great success story for all involved in the project.
If you like to travel, working within quality presents plenty of opportunity which may be to other Pharma Services sites or to third party manufacturers and vendors based around the globe.
With the rapid growth of the company there are plenty of opportunities for career progression and I have taken advantage of a number of these opportunities within both QC and QA, building on my skills and knowledge of the industry. QP training has been the most recent opportunity for me with Almac fully funding the MSc course and associated expenses, highlighting their commitment to invest in personnel.
Can you outline your career within Almac to date?
I have been with Almac 8 years working in Quality related roles both in Quality Control and Quality Assurance departments. I started in Almac as a QC technician in 2011 responsible for sampling, performing production checks and incoming goods checks. In 2012 I became an Analyst in the QC Chemistry lab. Here I was responsible for incoming raw material testing and the release testing of manufactured products. In 2015 I decided to move to a more office based job that will expose me to the workings of the entire business unit and so I became a Product Quality Officer. This role had me assigned as the QA contact to various manufacturing projects ensuring the quality and regulatory aspects were in place and adhered to from pre-product launch through to routine supply. In 2016 I promoted to QA Specialise and involved with the setting up of our new facility in Charnwood. This role exposed me to all aspects of quality assurance and validation. Almac is a rapidly growing organisation and in 2017 Almac identified the need to expand its QP resource to align this growth. I was the successful candidate and began a QP training programme in Jan 2018. In Jan 2019 I returned to Craigavon to the Trainee QP role prior to finishing my course and being eligible to act as a QP on an Almac manufacturing license.