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IT Business Analyst - PAS-X MES Upgrade (Contract)

astrazeneca · Australia – New South Wales

New
Contract Senior 🇬🇧 English
SAP PAS-X GxP 21 CFR Part 11 Annex 11 GAMP 5 LIMS ISA-95 ISA-88

Job description

About the role

AstraZeneca is hiring a contract IT Business Analyst for a 12-month position starting in January 2027, based onsite at its North Ryde pharmaceutical manufacturing plant in Sydney. You will lead the local delivery of the PAS-X (MES) upgrade, from requirements through to go-live and hypercare, while keeping production running and the system validated.

Key responsibilities

  • Lead local upgrade delivery: scope, plan, RAID logs and status reporting.
  • Capture requirements and assess impact on configuration, interfaces and master batch records (eBRs).
  • Produce GxP validation documentation in line with 21 CFR Part 11 and Annex 11.
  • Coordinate testing (IQ/OQ/PQ support, 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.

Required profile

  • Degree in information systems, computer science or a related field (or equivalent experience).
  • 3+ years 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 GxP knowledge: 21 CFR Part 11, Annex 11, GAMP 5 and risk-based validation.
  • Agile or hybrid project delivery, including test planning, release and change control.
  • Strong communication and stakeholder skills, able to work independently from day one.
  • Valid Australian work rights; Working Holiday visa holders (subclass 417 or 462) considered subject to visa conditions.

Required skills

  • SAP and Koerber (Werum) PAS-X
  • GxP validation (21 CFR Part 11, Annex 11, GAMP 5)
  • Desirable: multi-site or multi-environment upgrade experience, LIMS, data historians, ISA-95/ISA-88, SAP integration patterns (BAPIs/IDocs, web services) and interface testing

What we offer

  • Onsite parking and public transport access at North Ryde.
  • 12-month contract with start date January 2027.

Questions fréquentes

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Le contrat proposé est un Contract basé à Australia – New South Wales.
Source : ats:workday

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Published 8 hours ago

Expires 1 month from now

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astrazeneca

Australia – New South Wales