Job Summary
The QA In-Process Control (IPC) Officer is responsible for ensuring the quality and compliance of all manufactured and packaged products by performing rigorous quality checks and enforcing adherence to cGMP standards throughout the production lifecycle. This role is crucial for maintaining product integrity, proper documentation, and regulatory compliance.
Key Responsibilities
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Execute In-Process Control (IPC) checks for all manufacturing and packaging steps.
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Conduct acceptance sampling and testing of raw materials and finished products.
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Perform line clearance inspections on production equipment to ensure readiness for new batches.
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Verify the weight and quantity of dispensed raw materials prior to preparation processes.
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Assure product compliance with established specifications and maintain proper documentation throughout the production process.
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Enforce and monitor employee adherence to current Good Manufacturing Practices (cGMP).
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Inspect and manage the handling of returned products from the market.
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Lead investigations into quality deviations and incidents to identify root causes and propose corrective actions.
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Review and approve batch documentation for product release.
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Manage the circulation of wallet documents and process order revisions.
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Act as a liaison for the Egyptian Drug Authority (EDA) during inspector visits and ensure all regulatory requirements are met.
Qualifications & Skills
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Strong knowledge of cGMP, quality assurance principles, and regulatory requirements.
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Excellent attention to detail and a methodical approach to quality control.
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Ability to conduct thorough investigations and document findings accurately.
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Strong communication and interpersonal skills to effectively enforce quality standards.
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Proficiency in reviewing technical documents and process orders.
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Problem-solving skills and the ability to work effectively in a fast-paced manufacturing environment.
Education & Experience
- Bachelor's degree in Pharmacy.
- No Experience Required