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 offers an exceptional work environment for aspiring scientists at our Elstree, Hertfordshire site, where you can make a meaningful impact in the biopharmaceutical industry. With a strong focus on employee development, you will receive hands-on training from experienced professionals, fostering your growth in laboratory skills and analytical techniques. Our supportive culture encourages collaboration and innovation, making it an ideal place for recent graduates to launch their scientific careers.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Officer in Elstree
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We think you need these skills to ace Quality Assurance Officer in Elstree
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Kedrion Biopharma!
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Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Kedrion Biopharma, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Kedrion Biopharma
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Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Kedrion Biopharma that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Kedrion Biopharma’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
