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Analyste Physico‑Chimique – Environnement Stérile

El Kendi, part of MS Pharma · Alger

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GMP GLP calibration deviation management change control

Description du poste

About the role

The Physico‑Chemical Analyst will perform chemical and physical testing of products and materials within a sterile environment. Working according to standard operating procedures, the analyst ensures that all results meet approved specifications and are accurately documented for the supervisory team.

Key responsibilities

  • Receive monthly programs and daily tasks from the supervisor and configure analytical instruments, verifying qualification and calibration before use.
  • Prepare reagents, chemicals, and auxiliary solutions according to schedule.
  • Conduct physical and chemical analyses of validation product samples, following SOPs and local GMP/GLP guidelines.
  • Compare analytical results with specification limits, perform necessary calculations, and draft detailed reports.
  • Enter results into designated systems and maintain complete analysis records.
  • Perform sampling, testing, and reporting for cleaning validation.
  • Validate analytical methods and manage validation samples.
  • Communicate analytical data to Quality Assurance, Validation, and Production departments.
  • Track finished‑product release and raw‑material purchase orders.
  • Apply GMP and GLP practices throughout all laboratory activities.
  • Suggest process improvements and cost‑reduction ideas.
  • Maintain laboratory cleanliness, label prepared solutions, and conduct instrument calibrations.
  • Manage reagent and spare‑part inventories.
  • Initiate deviation reports and change‑control procedures when required.
  • Operate and clean laboratory equipment according to SOPs.

Required profile

  • Master’s degree (Master 2, Ingéniorat, Bac + 5) in chemistry, pharmaceutical sciences, or a related field.
  • 1–5 years of experience in a pharmaceutical or sterile‑environment laboratory.
  • Strong knowledge of GMP and GLP requirements.
  • Ability to follow detailed SOPs and produce accurate documentation.

Required skills

  • Analytical instrumentation
  • Method validation
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • Calibration of laboratory equipment
  • Deviation and change‑control management
  • Inventory management for reagents and spare parts

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El Kendi, part of MS Pharma

Alger