At a Glance
- Tasks: Ensure quality standards in production and engineering while resolving quality incidents.
- Company: Join Kedrion Biopharma, a leading biopharmaceutical company dedicated to excellence.
- Benefits: Enjoy a competitive salary, pension, life insurance, and employee discounts.
- Other info: Dynamic 24/7 shift pattern with excellent career growth opportunities.
- Why this job: Make a real impact in the pharmaceutical sector and contribute to life-saving therapies.
- Qualifications: Experience in a regulated quality environment and knowledge of quality management systems.
The predicted salary is between 24000 - 36000 £ per year.
Join our dynamic team in Elstree, Hertfordshire, as a Quality Assurance Officer and make a significant impact across various departments, including Production, Engineering, and Technical. In this role, you'll be at the forefront of ensuring timely resolution of quality incidents and deviations using Trackwise, while also maintaining compliance with quality systems through thorough auditing and essential training.
As the main QA point of contact during shifts, you'll play a pivotal role in promptly reviewing Batch Process Records and conducting walk rounds in different departments to uphold the highest quality standards throughout our facility. This position offers an exciting opportunity for individuals with previous experience in the pharmaceutical sector to excel and contribute to our mission of delivering excellence.
This role is on a 24/7 shift - 4 days on, 4 off, 4 nights on, 4 off - 12 hour shifts - 7am - 7pm and 7pm to 7am.
Duties & Responsibilities:
- Be the primary QA contact across site throughout shift, discerning major or critical deviations.
- Receive, review and process quality reports on Trackwise (e.g. DR/QI/CAPA records) according to defined procedures.
- Request, discuss and agree actions in response to a range of quality records including deviations, complaints and control changes as required.
- Ensure that any documents presented for QA approval/checking are complete.
- Ensure a standard approach to quality systems throughout the facility by undertaking both internal quality audits and QA inspections of facilities and activities.
- Ensure concerns regarding product safety and quality are drawn to the attention of colleagues and appropriate staff, including QA Management.
- Co-ordinate and maintain the files for a range of quality records as required.
- Perform QA AQL sampling for Finished Products Inspection.
- Review Autoclave Batch Processing Records.
- Perform regular audits of the manufacturing facility and contribute to continuous improvement activities.
- Participate as required in Regulatory and customer audits.
- Undertake work related to job objectives as directed by QA management.
Skills & Education required:
- Experience of working within a (bio) pharmaceutical, clean room or manufacturing environment.
- Experience of working within regulated Quality environment.
- Knowledge, understanding and experience of Quality Management Systems including CAPA’s, Deviations and Root Cause Analysis.
- Understanding of GMP and GxP.
- Knowledge of sterile aseptic filling and packing manufacturing processes is desirable.
- A natural tendency towards continuous improvement is required.
- Experience with blood products is desirable but not essential.
- Experience of working with documentation and quality management systems desirable.
We are seeking highly motivated and experienced individuals to drive our business forward. If you have a passion for excellence and aspire to work within a reputable pharmaceutical company, we want to hear from you.
In return we offer:
- Pension
- Life insurance
- On-site parking
- Employee assistance programme
- Virtual GP
- Cycle to work scheme
- Subsidised canteen
- Employee discounts and cash back
- Family friendly policies
- Employee recognition programme
Kedrion Biopharma is a biopharmaceutical company headquartered in Italy dedicated to collecting and fractionating blood plasma to produce and distribute plasma-derived therapies worldwide. These treatments help manage and prevent rare, ultra-rare, and debilitating conditions, including Coagulation and Neurological Disorders, Immunodeficiencies, and Rh sensitization.
The Kedrion group has numerous legacies within its brand; your employer will be Bio Products Laboratory Ltd, doing business as Kedrion Biopharma UK. Our plant is based in Elstree and counts nearly 1000 colleagues across various departments.
Since its foundation, Kedrion has experienced consistent growth, backed by strong performance indicators. Today, the company employs 5,200 people globally who work collaboratively on our portfolio of 38 life-enhancing plasma-derived products distributed in over 100 countries.
Our site is not easily accessible by public transport so please take this into consideration when applying as this role is fully on-site. Please apply today for immediate consideration.
Quality Assurance Officer in Elstree employer: Kedrion Biopharma
Kedrion Biopharma is an exceptional employer located in Elstree, Hertfordshire, offering a dynamic work environment where Quality Assurance Officers can thrive. With a strong commitment to employee growth, the company provides comprehensive benefits including life insurance, an employee assistance programme, and a cycle-to-work scheme, all while fostering a culture of collaboration and continuous improvement. Join us to make a meaningful impact in the biopharmaceutical sector, contributing to life-enhancing therapies in a supportive and innovative setting.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Officer in Elstree
✨Tip Number 1
Network like a pro! Reach out to current employees at Kedrion Biopharma on LinkedIn. A friendly message can go a long way in getting your foot in the door and showing your genuine interest in the Quality Assurance Officer role.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of GMP and GxP. We want to impress them with our understanding of quality management systems, so be ready to discuss how you've applied these principles in past roles.
✨Tip Number 3
Showcase your problem-solving skills! Be prepared to share examples of how you've handled quality incidents or deviations in previous jobs. This will demonstrate your ability to think on your feet and maintain high standards.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining the team at Kedrion Biopharma.
We think you need these skills to ace Quality Assurance Officer in Elstree
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Assurance Officer role. Highlight your experience in the pharmaceutical sector and any relevant quality management systems you've worked with. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to our mission at Kedrion Biopharma. Keep it concise but impactful – we love a good story!
Showcase Relevant Experience:When filling out your application, be sure to showcase any specific experiences related to GMP, GxP, or quality audits. We’re keen on candidates who have a natural tendency towards continuous improvement, so let that shine through!
Apply Through Our Website:Don’t forget to apply through our website for the best chance of getting noticed! It’s the easiest way for us to keep track of your application and ensure it gets into the right hands. We can’t wait to hear from you!
How to prepare for a job interview at Kedrion Biopharma
✨Know Your Quality Systems
Familiarise yourself with Quality Management Systems, especially CAPA, Deviations, and Root Cause Analysis. Be ready to discuss how you've applied these in previous roles, as this will show your understanding of the quality landscape in the pharmaceutical sector.
✨Showcase Your Auditing Skills
Prepare examples of past internal audits or QA inspections you've conducted. Highlight your ability to maintain compliance and improve processes, as this is crucial for the role at Kedrion Biopharma.
✨Demonstrate Your Problem-Solving Ability
Be prepared to discuss specific instances where you identified a major deviation and how you resolved it. This will illustrate your critical thinking skills and your proactive approach to quality assurance.
✨Understand the Shift Dynamics
Since this role involves 12-hour shifts, be ready to talk about your experience with shift work and how you manage your time effectively. Showing that you can adapt to this schedule will be a plus in your interview.
