Specialist Quality - Environmental Assurance (12 Month Secondment/FTC)

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:

1. Ensure an effective microbiological, particle, and physical monitoring program is established and maintained.
2. Provide technical advice on clean room standards, good aseptic practices, associated cGMPs, and their impact on procedures/manufacture.
3. Assist in major failure investigations, ensuring recommendations for product disposition are documented.
4. Maintain and develop your professional capability.
5. Provide training and coaching to personnel.
6. Perform MSDM documentation updates.
7. Conduct self-inspections and observations.
8. Review batches.
9. Manage OCM Change control.
10. Establish and maintain an effective aseptic gowning and Operator Media Trial program.
11. Proactively suggest improvements to enhance environmental compliance.
12. Maintain high environmental standards in production and QC testing clean rooms.
13. Participate in regulatory and internal audits and inspections.
14. Contribute to the preparation of regulatory submissions.

Essential Skills/Experience:

1. Qualified to degree level or equivalent in one of the sciences or with working experience in a GMP environment.
2. Sound knowledge and understanding of the principles of aseptic manufacture and associated GMPs.
3. Essential Functional Capability at the Professional level in Aseptic Manufacture and Environmental Control.
4. Knowledge of Current GMP requirements related to technical expertise and regulatory processes.

Desirable Skills/Experience:

1. Knowledge of microbiological and physical environmental monitoring.

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!

Date Posted: 07-Apr-2025

Closing Date: 21-Apr-2025

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.