In-Process Control Quality Officer
Parkville · Damiette
وصف الوظيفة
About the role
The In-Process Control Quality Officer ensures that pharmaceutical manufacturing and packaging operations meet approved SOPs, specifications, and regulatory standards. This role supports product quality by monitoring critical parameters and performing real‑time testing throughout the production line.
Key responsibilities
- Perform in‑process controls during manufacturing and packaging according to SOPs.
- Verify and monitor critical process parameters (CPPs) and critical quality attributes (CQAs).
- Conduct line clearance before batch start, product changeover, and after batch completion.
- Collect in‑process samples and execute tests such as weight variation, hardness, friability, disintegration, pH, viscosity, and fill volume.
- Record results in real time on Batch Manufacturing Records (BMR) while ensuring Good Documentation Practices (GDP) and Data Integrity (ALCOA+).
- Carry out Acceptance Quality Limit (AQL) inspections and support supplier performance evaluations.
- Report deviations, OOS, or OOT results and assist in investigations, CAPA, change control, and complaint handling.
- Participate in risk assessments as required.
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.
- Willingness to work on‑site in Alexandria, Cairo or Damietta.
Required skills
- Weight variation testing
- Hardness testing
- Friability testing
- Disintegration testing
- pH measurement
- Viscosity measurement
- Fill volume measurement
- AQL inspection
- Good Documentation Practices (GDP)
- Data Integrity principles (ALCOA+)
- GMP compliance
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Parkville
Damiette
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