At a Glance
- Tasks: Support quality assurance in aseptic manufacturing and ensure compliance with regulations.
- Company: Join AstraZeneca, a leader in innovative healthcare solutions.
- Benefits: Gain valuable experience in a collaborative environment with a focus on patient care.
- Other info: Inclusive workplace that values diverse perspectives and offers career growth opportunities.
- Why this job: Make a real impact on product quality and patient safety every day.
- Qualifications: Degree in sciences or GMP experience required; knowledge of aseptic manufacture is a plus.
The predicted salary is between 40000 - 50000 £ per year.
Join us as a Quality Specialist and provide QA support for aseptic manufacturing, ensuring that operations meet all the regulatory and AstraZeneca standards and the appropriate level of compliance. Your role will directly impact the value stream by supporting and influencing decisions through advice to others.
Accountabilities:
- Provide Quality Assurance support to the manufacturing team
- Provide technical advice on GMP requirements, quality standards, and the compliance impact of manufacturing and operational activities
- Support investigations and ensure appropriate root cause analysis and effective corrective and preventative actions are implemented
- Triage, review and close deviations and associated investigations within agreed timelines
- Support the complaints management process and, where appropriate, review and approve complaint investigations
- Maintain and develop your professional capability
- Provide training and coaching to personnel
- Perform MSDM documentation updates
- Conduct self-inspections and observations
- Review batch records
- Manage OCM Change control
- Proactively suggest improvements to enhance quality compliance
- Maintain high quality standards in production and QC testing clean rooms
- Participate in regulatory and internal audits and inspections
Essential Skills/Experience:
- Qualified to degree level or equivalent in one of the sciences or with working experience in a GMP environment.
- Sound knowledge and understanding of the principles of aseptic manufacture and associated GMPs.
- Essential Functional Capability at the Professional level in Aseptic Manufacture and Environmental Control.
- Knowledge of Current GMP requirements related to technical expertise and regulatory processes.
Desirable Skills/Experience:
- Experience with deviation management, change controls, complaints and batch record reviews
- Experience driving continuous improvement initiatives within a GMP environment
- Understanding of Product Quality Reviews and audit/inspection management
AstraZeneca offers a unique opportunity to be at the forefront of quality assurance, where your work is both important and valued. Our forward-looking mindset allows you to add real value throughout the lifecycle of our products, from discovery to commercialization. As the voice of the patient, every batch you certify is a personal stamp of approval. We are always innovating, trialing the latest models and technologies to improve reliability and excellence in our processes. Here, you'll feel empowered to make decisions that put patients first, working in a collaborative environment that values each voice.
Ready to make a difference? Apply now to join our team!
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
Specialist - Quality Assurance - 12 Month Secondment/FTC in Macclesfield employer: AstraZeneca
AstraZeneca is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the heart of Cambridge. Employees benefit from extensive professional development opportunities, a commitment to diversity and inclusion, and the chance to make a meaningful impact in the pharmaceutical industry through cutting-edge research and AI integration.
StudySmarter Expert Advice🤫
We think this is how you could land Specialist - Quality Assurance - 12 Month Secondment/FTC in Macclesfield
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
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Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like AstraZeneca.
We think you need these skills to ace Specialist - Quality Assurance - 12 Month Secondment/FTC in Macclesfield
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at AstraZeneca.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at AstraZeneca. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at AstraZeneca
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with AstraZeneca.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help AstraZeneca achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
