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Specialist Quality - Environmental Assurance (12 Month Secondment/FTC)
Salary not available. View on company website.
ASTRAZENECA UK LIMITED, Macclesfield, Cheshire East
- Onsite working
- Full time
- Temporary
Posted 5 days ago, 8 Apr
Job ref: e373f68c584c4bfa91ed61834c63822c
Full Job Description
- Provide technical advice on clean room standards, good aseptic practices, associated cGMPs, 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.
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.
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.
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