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AstraZeneca
,
Macclesfield, Cheshire
Sterile Manufacturing Officer
Overview
Job Description
Sterile Manufacturing Officer Macclesfield 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, we don't follow the crowd and that means we don't expect our people to either. To develop life-changing medicines we approach problems in a different way - agile and nimble, and focused 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 the opportunity you are looking for! You could join a technical team with responsibilities for process robustness and continuous improvement associated with aseptically prepared and terminally sterilised products and associated APIs, manufactured at Macclesfield. You'll interface across departments to support and lead improvement projects to deliver enhanced sterility 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 discussing any related activities during Regulatory Authority inspections. Responsibilities: You will be involved in evaluating and assessing technical issues to aid the resolution of quality incidents associated with the sterility assurance of products. Providing aseptic expertise and resource to your local business area, you'll develop strong relationships with the Sterile Manufacturing Specialist, Production, Microbiology, Technical Engineering and Quality functions. This will enable timely progression and resolution of issues positively and in the best interest of AstraZeneca. With your hardworking approach you'll be fundamental in identifying and delivering sterile product related 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 to improve compliance. With strong network skills and ambition you'll maintain and improve your own areas of technical competence and expertise. This will then assist you in providing initial and ongoing training and guidance on standard methodologies for ongoing aseptic security at AstraZeneca's Macclesfield site. Essential requirements: * A scientific/technical degree or equivalent and experience of working in a GMP sterile environment * Confirmed experience of project delivery in a sterile manufacturing environment. * Experience in clean room technologies, sterile manufacture, sterilisation and basic microbiology * Good working knowledge of "Annex 1 Manufacture of Sterile Medicinal Products", FDA "Sterile Drug Products Produced by Aseptic Processing" and ISO 14644 * Ability to make complicated judgements within general operating guidelines and a systematic approach to problem solving * Excellent planning and interpersonal skills * Excellent verbal and written communication at all levels and effective influencing skills to build positive relationships with customers. * Ideally, you'll have exposure of working within multiple aseptic or sterile manufacturing facilities, however this is not essential. Date Posted 28-May-2020 Closing Date 14-Jun-2020 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.