Quality Assurance Officer - IPC

Job Scope

Control the product process, control the quality of the products and insure accurate application of GMP rules in every step of production.

Job Requirements

Education

B.Sc. or Diploma Degree in pharmacy, chemistry or Chemical engineering...

Experience

0-2 years’ experience in related field.

Language

Good written, read and spoken Arabic and English Languages

Professional Knowledge

• Knowledge in the systems such as ICH, GMP, GLP, WHO
• Knowledge in the published instructions of the specifications (FAQ’s published specifications)
• Knowledge in the procedures of obtaining quality certificate from official entities
• Knowledge in production area layout design
• Knowledge in material, process and people flow
• Knowledge in Trend Analysis
• Knowledge in documentation control systems
• Knowledge in Tracking Systems
• Knowledge in good documentation practices
• Statistical analysis
• Best archiving practices
• Failure investigations
• Systems development & workflow

Duties and Responsibilities (But not limited to)

Product Inspection & Approval:

• Check products at each production stage as per Acceptable Quality Limit SOP and approve the transition to the next stage.
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• Review batch records and ensure compliance with GMP and company SOPs before and after production stages.

GMP Compliance & Documentation:

• Ensure GMP compliance during daily batch manufacturing activities (housekeeping, line clearance, deviations, calibration, etc.).
• Perform daily and periodic GMP compliance tours in production areas and ensure proper room, material, and product identification.
• Ensure that equipment and balances in the IPC department are calibrated and within calibration timelines.
• Review and approve manufacturing forms (MF, PF, MI, PI) and assess deviations, change controls, and CAPAs.
• Review and archive documentation in compliance with good documentation practices.

Failure Investigation & CAPA:

• Conduct failure investigations for production failures and Out of Specification (OOS) issues.
• Follow up on failure reports and implement corrective and preventive actions (CAPAs).
• Log received deviations and support the QA Senior Officer or Supervisor in their resolution.

Quality Control & Coordination:

• Coordinate with Quality Control and Microbiology departments for analysis functions and batch size determination.
• Coordinate with the Maintenance Department for preventive and corrective maintenance activities.
• Collaborate with the Regulatory Affairs Department to follow up on product registration and shelf-life-related issues for each market.

Production Oversight & Monitoring:

• Monitor pressure differences, temperature, and humidity levels to ensure they are within allowable limits and coordinate with Utilities.
• Oversee production resource utilization to ensure efficiency.
• Provide guidance on machine capacity and operations to production staff.

Training & Development:

• Train new staff on system changes and updates in GMP or SOP requirements.
• Prepare summaries related to QA activities (failure investigations, self-inspections, reprocessing evaluations, and change control requests).

Audit Preparation & Compliance:

• Prepare for internal and external audits and ensure compliance with regulatory requirements.
• Ensure proper documentation and material handling in the warehouse as per Good Storage Practices.