At a Glance
- Tasks: Ensure microbiological expertise in clean room operations and maintain environmental control.
- Company: Join AstraZeneca, a leader in quality assurance with a collaborative culture.
- Benefits: Competitive salary, inclusive environment, and opportunities for professional growth.
- Other info: Empowerment to innovate and contribute to regulatory submissions and audits.
- Why this job: Make a real impact on patient safety and product quality in a dynamic setting.
- Qualifications: Degree in science or GMP experience; knowledge of aseptic manufacture is essential.
The predicted salary is between 35000 - 42000 £ per year.
Specialist Quality - Environmental Assurance (12 Month Secondment/FTC)
Introduction to role
Join us as a Specialist Quality - Environmental Assurance and provide essential microbiological expertise and support for our manufacturing processes.
Oversee aseptic and clean room operations, ensuring particle, physical, and microbiological environmental control in production and QC testing facilities.
Your role will directly impact the value stream by influencing clean room decisions and maintaining compliance with current regulations.
Accountabilities
- Ensure an effective microbiological, particle, and physical monitoring program is established and maintained.
- Provide technical advice on clean room standards, good aseptic practices, associated c GMPs, and their impact on procedures/manufacture.
- Assist in major failure investigations, ensuring recommendations for product disposition are documented.
- Maintain and develop your professional capability.
- Provide training and coaching to personnel.
- Perform MSDM documentation updates.
- Conduct self-inspections and observations.
- Review batches.
- Manage OCM Change control.
- Establish and maintain an effective aseptic gowning and Operator Media Trial program.
- Proactively suggest improvements to enhance environmental compliance.
- Maintain high environmental standards in production and QC testing clean rooms.
- Participate in regulatory and internal audits and inspections.
- Contribute to the preparation of regulatory submissions.
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
- Knowledge of microbiological and physical environmental monitoring.
Astra Zeneca 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!
- Date Posted
- Closing Date
Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at Astra Zeneca 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 - Environmental 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 - Environmental 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 - Environmental 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.
