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