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AstraZeneca Pharmaceuticals LP
,
Macclesfield, Cheshire
Quality Assurance Associate (Computer Systems) - 12 month fixed term contract
Overview
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. We have an excellent opportunity for a Quality Assurance Officer to join our hardworking team for 12 months. Responsibilities: You'll support a network of Quality Assurance Associates in their day to day role and work with global IT for Enterprise Systems to support business change and BAU. As the primary site QA contact you'll have accountability for computerised systems to ensure the effective and compliant management of change control, validation, system testing and deviations/incidents from a GMP perspective. This role is a fantastic opportunity to collaborate with our talented teams of Quality professionals across the business. Together you will ensure consistent application and execution of key quality systems related to the quality assurance of computerised systems on site. Proactive by nature, you will look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whist ensuring an appropriate level of compliance. You will collaborate in data analysis and report creation on quality metrics and key performance indicators related to area of responsibility. Experience and skills required: + You should hold a Degree or equivalent professional qualification in a science / technical field such as Pharmacy, Chemistry, Biology or Engineering. + With prior experience in Good Manufacturing Practice, you will ideally have comprehensive knowledge of international GMP requirements /quality systems and Pharmaceutical manufacturing/packing and testing technologies. + A comprehensive knowledge of and application of cGMP requirements of Quality Management Systems. + It would be desirable for you to have experience of Process Control, Laboratory Systems or SAP processes. + With a high level of technical process understanding across a range of manufacturing areas, you will hold a comprehensive working knowledge of regulatory interactions and compliance procedures. + Proven influencing and negotiating skills, with a high level of customer focus and strong ability to reinforce and maintain quality standards. You will also be comfortable leading a complex and changing workload.