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AstraZeneca

Global pharmaceutical company developing prescription medicines

IT Business Analyst - PAS-X MES Upgrade

Enterprise ApplicationsConfirmed live in the last 24 hours
Full-timeSydney NSW, AustraliaNo salary listed

About the Job

Requirements

  • A degree in information systems, computer science or a related field, or equivalent experience.
  • At least 3 years of experience as an IT Business Analyst in pharma, biotech or regulated manufacturing.
  • Hands-on experience with SAP and Koerber (Werum) PAS-X, including a PAS-X upgrade or major release.
  • Strong knowledge of GxP, 21 CFR Part 11, Annex 11, GAMP 5 and risk-based validation.
  • Experience with Agile or hybrid project delivery, including test planning, release and change control.
  • Strong communication and stakeholder skills, and ability to work independently from day one.
  • Valid Australian work rights; candidates on Working Holiday visas (subclass 417 or 462) may be considered subject to their visa work conditions.

Responsibilities

  • Lead local PAS-X upgrade delivery from requirements through go-live and hypercare while keeping production running and the system validated.
  • Manage upgrade scope, planning, RAID logs and status reporting.
  • Capture requirements and assess impacts on configuration, interfaces and electronic master batch records (eBRs).
  • Produce GxP validation documentation in line with 21 CFR Part 11 and Annex 11.
  • Coordinate testing, including IQ/OQ/PQ support and user acceptance testing (UAT), cutover and go-live readiness.
  • Support PAS-X integration with SAP and shop-floor equipment.
  • Work with the vendor and global program office, provide hypercare, and hand over to business-as-usual support.

Desired Qualifications

  • Multi-site or multi-environment upgrade experience.
  • Familiarity with LIMS, data historians and ISA-95/ISA-88.
  • Exposure to SAP integration patterns (BAPIs/IDocs and web services) and interface testing.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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