Environmental Assurance Officer

AstraZeneca Pharmaceuticals LP ,
Macclesfield, Cheshire
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Job Description

At AstraZeneca, we're not afraid to do things differently. We're building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening up new ways to work, pioneering cutting edge methods and bringing unexpected teams together. At AstraZeneca every one of our employees makes a difference to patient lives every day. You may not feel you're at the frontline of research but your role in changing patients' lives is critical. Our mission is ambitious and it takes the skills of a collaborative team to really deliver on what science can do. Do you have a science background and knowledge of what it takes to work in aseptic and clean room manufacturing environment? If so and you are looking for your next exciting challenge to become an authority in Environmental Assurance, then this role may be the ideal opportunity for you to develop your skills. A key member of the Environmental Support Team, you'll focus on overseeing the aseptic and clean room operations with respect to physical and microbiological environmental control in production and Quality Control testing facilities. Located at our Macclesfield Campus you'll be aligned with the Quality Assurance function supporting aseptic and clean room manufacture. You will oversee aseptic and clean room operations in relation to physical and microbiological environmental control in production and QC testing facilities. Dedicated in nature you will positively impact directly on the value stream by ensuring the physical and environmental monitoring programme is maintained in compliance with current regulations. As you'll be working in an aseptic environment you should be adherent to a high level of required standards. Responsibilities: + Based on plant you'll focus your work across the aseptic manufacturing facilities as the business demands require + Working within an aseptic environment, you'll need to obtain an aseptic license to enter the aseptic processing areas + Responsibility will be with you for the for daily assessment of the working environment to support manufacture. This includes environmental batch reviews, deviation manager responsibilities, provision of technical and practical advice to manufacturing personnel for issue management and detailed analysis of data to provide compliance reporting + A confident and clear communicator, you will be responsible for providing mentoring and training in good aseptic practices including aseptic gowning and Operator Media Trial and associated cGMPs + We'll look to you to provide authoritative technical advice on cleanroom disciplines and environmental assurance principles during internal and regulatory inspections Essential skills and experience: + Ideally qualified to degree level/equivalent experience in one of the sciences or you will have experience of working in a GMP environment, ideally in the area of microbiological and physical environmental monitoring + We're looking for a sound knowledge and understanding of the principles of aseptic manufacture, associated GMP's and an understanding of Safety, Health and Environmental principles Desirable: + Ability to analyse Issues/develop Solutions + Assures Quality and Compliance + Risk Management experience + Knowledge of microbiological and physical environmental monitoring + Aseptic techniques and clean room experience

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