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In-Process Control Quality Officer

Parkville · Alexandrie

Junior 🇬🇧 English
Good Documentation Practices

Job description

About the role

The In‑Process Control Quality Officer will ensure that pharmaceutical manufacturing and packaging operations meet all quality and regulatory standards. Working on the production floor, you will perform real‑time testing, monitor critical parameters, and document results to support product release.

Key responsibilities

  • Execute in‑process controls according to SOPs, including line clearance before batch start, product changeover, and after batch completion.
  • Collect and test in‑process samples for weight variation, hardness, friability, disintegration, pH, viscosity, and fill volume.
  • Record results in real time on Batch Manufacturing Records and ensure compliance with Good Documentation Practices (GDP) and Data Integrity (ALCOA+).
  • Monitor critical process parameters (CPPs) and critical quality attributes (CQAs) and report deviations, OOS or OOT findings.
  • Perform Acceptance Quality Limit (AQL) inspections and support supplier performance evaluations.
  • Participate in deviation investigations, CAPA, change control, customer complaint investigations, and risk assessments.

Required profile

  • Bachelor’s degree in Pharmacy, Chemistry or Pharmaceutical Sciences.
  • 1–2 years of experience in pharmaceutical manufacturing, in‑process control, quality assurance or quality control.

Required skills

  • Weight variation, hardness, friability, disintegration, pH, viscosity and fill‑volume testing.
  • Good Documentation Practices (GDP) and Data Integrity (ALCOA+).
  • GMP and regulatory compliance.
  • AQL inspection techniques.

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Published 3 months ago

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Parkville

Alexandrie