Job Purpose :
To ensure that all validation activities and operational quality systems are executed in compliance with quality standards , internal policies, and regulations.
Key Responsibilities :
1. Validation process
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Develop and implement quality management strategy for Validation and Calibration processes.
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Develop and maintain systems to establish standards relating to activities and production processes.
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Participating & Supervising GMP Projects:
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Checking & approving the site validation review plans for:
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Building.
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HVAC system.
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Services.
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Equipment.
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Ensuring that all validation activities and documentation are complying with the recommendations of validation master plan.
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Supervising, follow up and participate in changing control system.
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Supervising Preparing of Validation Master Plans (VMP),Performance Qualification Protocols(PQPs) and Validation reports(VR) for different validation activities such as:
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Process validation.
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Validation Review for whole activities.
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Process Equipment qualification.
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Facility qualification.
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CSV and software Validation.
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Confirming the nonconformity and determining the disposition of nonconforming food materials.
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Oversee the internal food safety audit program
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Select internal audit personnel, review results of food safety audits, ensure that corrective actions are understood, and supervise corrective actions.
2. Shipping & Receiving Control
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Verify vehicle conditions during loading/unloading (temperature, cleanliness, integrity, and absence of damage or contamination).
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Ensure products are compacted and stacked according to company standards.
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Check that products are received and entered correctly, ensuring batches are not mixed.
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Inspect products upon receipt/shipment for safety, production dates, operation numbers, and isolate damaged goods in a designated quarantine area.
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Review and document reasons for returns, sign return records, and escalate when necessary.
3. Printing & Labeling Quality Control
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Ensure the clean room is properly sanitized before printing operations.
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Verify product quantities and details of messages to be printed.
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Monitor and confirm accuracy of product printing processes.
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Validate that printed data matches required product specifications.
4. Vehicle & Equipment Hygiene
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Inspect transport vehicles for cleanliness inside and outside.
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Ensure no perforations, odors, or sharp objects are present.
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Confirm compliance with hygiene and safety requirements before use.
5. Facility & Equipment Monitoring
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Inspect HVAC systems, store flooring, electrical lights, and drainage for malfunctions.
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Ensure there are no leaks, water damage, or hazards within operational areas.
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Escalate maintenance issues promptly to ensure operational continuity.
6. Warehouse Stock Quality
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Verify pallets are labeled, wrapped, and stored properly in designated locations.
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Ensure pallets are not damaged, open, or placed directly on the floor.
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Monitor compliance with SOPs and warehouse work systems.
7. Quality & Compliance Assurance
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Ensure the Quality Management System (QMS) is implemented and maintained.
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Address and follow up on customer complaints related to quality issues.
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Ensure all warehouse and logistics operations comply with GDP/GMP standards.
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Support internal and external audits, inspections, and regulatory requirements.
8. Health, Safety & Environmental Compliance
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Comply with OH&S policies, objectives, and training requirements.
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Report all incidents, accidents, or near-misses immediately.
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Comply with environmental management standards and report any environmental incidents.
Qualifications & Experience :
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Bachelor’s degree in pharmaceutical studies or science
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5- 7 years of experience in Quality Assurance/Quality Control within warehouse, logistics, or pharmaceutical/food industries.
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Strong knowledge of GMP, GDP, and validation guidelines
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strong leadership, communication, and analytical abilities.
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V. Good command of English both written and spoken.
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Excellent attention to detail, documentation, and reporting skills.