In-Process Control Quality Officer

“Parkville is committed to diversity, equity, and inclusion, and all employees are expected to support these values in all aspects of their work”

Job Responsibilities:

• Perform in-process controls during manufacturing and packaging operations according to approved SOPs and specifications.
• 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 according to approved sampling plans and SOPs.
• Perform in-process tests such as weight variation, hardness, friability, disintegration, pH, viscosity, and fill volume.
• Record all results accurately and in real time in Batch Manufacturing Records (BMR) and related documents.
• Ensure compliance with Good Documentation Practices (GDP).
• Ensure compliance with Data Integrity principles (ALCOA+).
• Ensure compliance with GMP, regulatory requirements, and company procedures.
• Perform AQL (Acceptance Quality Limit) inspection activities.
• Participate in supplier performance evaluation based on AQL results.
• Report deviations, Out-of-Specification (OOS), or Out-of-Trend (OOT) results to management.
• Support deviation investigations, CAPA, change control and customer complaint investigations activities.
• Participate in risk assessments when required.

Education:

Bachelor’s degree in pharmacy, Chemistry or pharmaceutical sciences.

Experience:

1- 2 years of experience in pharmaceutical manufacturing, IPC, Quality Assurance, or Quality Control.

Residency Requirement:

• Alexandria.