Manager - Information Technology (QA)

8 - 12 years

5 - 10 Lacs

Posted:4 days ago| Platform: Naukri logo

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Skills Required

Work Mode

Work from Office

Job Type

Full Time

Job Description

IT QA Specialist

Key Responsibilities

  • Ensure IT systems comply with GxP requirements (GMP, GDP, GLP)
  • Support IT quality processes including documentation, change control, deviations, and CAPA
  • Work with QA, regulatory, manufacturing, and laboratory teams to maintain compliance
  • Participate in audits and inspections; ensure readiness and complete documentation
  • Collaborate on implementation and maintenance of pharma IT systems
  • Perform risk assessments and ensure adherence to regulatory guidelines

Required Skills

  • Strong understanding of GxP (GMP, GDP, GLP)
  • Knowledge of regulatory frameworks:

    FDA 21 CFR Part 11, GAMP 5, ICH Q9, EU Annex 11

  • Experience working with pharma IT systems such as:
    • LIMS:

      LabWare, SampleManager
    • MES:

      Werum PAS-X, Emerson Syncade
    • ERP:

      SAP S/4HANA
    • QMS:

      MasterControl, TrackWise
    • DMS/EDMS:

      Veeva Vault, Documentum
  • Strong documentation & IT process discipline
  • Excellent communication, coordination, and stakeholder management skills

Educational Qualification

  • Bachelors degree in

    Computer Science, IT, Engineering, Life Sciences, Pharmacy

    , or related discipline

Preferred Certifications

  • ISTQB
  • GAMP 5
  • ISO 9001 / Quality Management
  • IT Quality / Compliance Training

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Swiss Garnier Life Sciences

Biotechnology

Zurich

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