Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives.
At Alexion AstraZeneca Rare Disease, people living with rare and devastating diseases are our Guiding Star.
We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives.
We value the uniqueness and diversity of our employees and recognize that nurturing the different perspectives and strengths of our people translates into innovative breakthroughs for patients.This is what you will do:This position will support the implementation, adoption and service management of IT Laboratory and QA systems across the Quality and Manufacturing Science and Analytical Technology (MSAT) functions to meet the business requirements.
Alexion's strategic goals and growth trajectory demand that we strive for operational streamlining and efficiency driven by lean digital solutions and processes.As a key point of contact for the Quality Control and MSAT Labs, you will act as IT System Owner and Subject Matter Expert for a number of critical lab systems.
This will involve oversight and accountability for BAU service management and IT support; along with IT projects and upgrades for the labs; working with our external partners and vendors.You will be responsible for:Key responsibilities of the IT System Analyst, Digital QC Lab are:Partner with the Business System and Process Owners for end-to-end lifecycle management of laboratory systems from procurement and sourcing through implementation and validation, BAU service management and decommissioning.Partner with the IT Capability Leads and Business Partners for lab systems to assess technology roadmap, capabilities and architecture needs.Consolidation of IT demand and enhancement requests from business into a defined backlog and roadmap that can be budgeted, planned for and executed upon.Requirements engineering, system design, configuration and build, testing and validation, documentation and training management for lab systems.Support business with quality record management including change, deviation and action management for lab systems.IT service management of lab systems including request, incident and IT change management, security and system administration (e.g.
access, licence, availability, vulnerability and patch management), continuity management (e.g.
backup and disaster recovery) and periodic review.Relationship management and oversight of external vendors to ensure Service Level Agreements and SoW breakthroughs are being met as applicable.Provide audit support for lab systems when required.You will need to have:Bachelor's degree or equivalent experience in Computer Science, Information Technology, Science, Engineering or a related field.Experience (3+ years) working in GxP Quality and Laboratory Systems DomainDirect experience working with the following systems:Laboratory Information Management Systems (e.g.
LabWare LIMS)Lab Execution Systems (e.g.
Biovia ONE Lab LES)Chromatography Data Systems (e.g.
Empower 3 CDS)Document Management Systems (e.g.
Veeva Vault QualityDocs)Quality Management Systems (e.g.
Veeva Vault QMS)Validation Lifecycle Management Systems (e.g.
ValGenesis and Kneat Gx)Scientific Data Management Systems (e.g.
Waters NuGenesis SDMS)Computer Systems Validation and GAMP 5 experienceAnalytical Instrument Validation and USP 1058 experienceExperience of Administerining On-Premises Infrastructure and Cloud HostingExperience with Administration of Segregated Lab NetworksExperience with IT Endpoint Asset ManagementIT Service Management (e.g.
ITIL 4 certification)IT Project Management (e.g.
CAPM, PMP certification)Experience (1-3 years) of Partner Relationship and Communication ManagementExperience (1-3 years) of Product/System Ownership and GovernanceWe would prefer for you to have:Master's Degree or equivalent experience in Computer Science, Information Technology, Science, Engineering or a related field.IT Business Analyst Certification (e.g.
IIBA CCBA or CBAP) / IT Product Owner Certification (e.g.
Certified Scrum Product Owner [CSPO] )IT Solution Architecture Certification (e.g.
AWS Solutions Architect)Strong leadership and problem-solving skillsFamiliarity with emerging technologies and industry trendsProven track record in successful systems project deliveryFlexibility for international travel and adaptability to a multicultural environmentDate Posted01-Aug-2024Closing Date01-Sep-2024Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.
We welcome and consider applications from all qualified candidates, regardless of characteristics.
We offer reasonable adjustments/accommodations to help all candidates to perform at their best.
If you have a need for any adjustments/accommodations, please complete the section in the application form.