Sterile Manufacturing Officer

AstraZeneca

Sterile Manufacturing Officer Macclesfield, Cheshire

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Job Description

Sterile Manufacturing Officer Macclesfield At AstraZeneca, we’re not afraid to do things differently. We’re building a new kind oforganisation to reset expectations of what a bio-pharmaceutical company can be. This means we’reopening up new ways to work, pioneering cutting edge methods and bringing unexpected teamstogether. At AstraZeneca, we don’t follow the crowd and that means we don’t expect our people to either. Todevelop life-changing medicines we approach problems in a different way – agile and nimble, andfocused on what our people need to make ground-breaking discoveries. Do you have experience of working within a GMP sterile environment? If so, this may be theopportunity you are looking for! You could join a technical team with responsibilities for process robustness and continuousimprovement associated with aseptically prepared and terminally sterilised products and associatedAPIs, manufactured at Macclesfield. You’ll interface across departments to support and lead improvement projects to deliver enhancedsterility assurance. By ensuring that manufacturing operations meet all the current regulatory,compliance and AstraZeneca standards and you will actively handle risk. We’ll expect you to ensure that these aspects are in place and you’ll be confident in discussingany related activities during Regulatory Authority inspections. Responsibilities: You will be involved in evaluating and assessing technical issues to aid the resolution of qualityincidents associated with the sterility assurance of products. Providing aseptic expertise and resource to your local business area, you’ll develop strongrelationships with the Sterile Manufacturing Specialist, Production, Microbiology, TechnicalEngineering and Quality functions. This will enable timely progression and resolution of issuespositively and in the best interest of AstraZeneca. With your hardworking approach you’ll be fundamental in identifying and delivering sterile productrelated technologies and best industry practices to your technical team and wider business area.This will involve proactively looking for opportunities to improve processes and procedures toimprove compliance. With strong network skills and ambition you’ll maintain and improve your own areas of technicalcompetence and expertise. This will then assist you in providing initial and ongoing training andguidance on standard methodologies for ongoing aseptic security at AstraZeneca’s Macclesfieldsite. Essential requirements: * A scientific/technical degree or equivalent and experience of working in a GMP sterileenvironment * Confirmed experience of project delivery in a sterile manufacturing environment. * Experience in clean room technologies, sterile manufacture, sterilisation and basicmicrobiology * Good working knowledge of “Annex 1 Manufacture of Sterile Medicinal Products”, FDA “Sterile DrugProducts Produced by Aseptic Processing” and ISO 14644 * Ability to make complicated judgements within general operating guidelines and a systematicapproach to problem solving * Excellent planning and interpersonal skills * Excellent verbal and written communication at all levels and effective influencing skills tobuild positive relationships with customers. * Ideally, you’ll have exposure of working within multiple aseptic or sterile manufacturingfacilities, however this is not essential. Start date : ASAP Skills : Sterile Manufacture Salary : Negotiable Apply Now

Sterile Manufacturing Officer Macclesfield, Cheshire

Apply Now

Tagged as: Sterile Manufacturing Officer