QA Validation Specialist At Rotabiogen for pharmaceutical and chemical investments
Company Description
HPG - Hefny Pharma Group is a national pharmaceutical company located in Cairo, Egypt, focused on manufacturing and selling high-quality pharmaceutical products. The company values innovation, quality, and accessibility, providing essential healthcare solutions to the community.
Role Description
This is a full-time on-site role for a Validation Specialist at HPG - Hefny Pharma Group in Cairo. The Validation Specialist will be responsible for tasks such as Computer System Validation, Process Validation, Quality Control, Quality Assurance, and Validation activities to ensure compliance and quality standards are met in pharmaceutical manufacturing.
Responsibility :
1. Responsible for execution, monitoring and reporting of the following:
1.1 All classified areas Qualification.
1.2 Holding time studies for Tanks.
1.3 Media fill aseptic simulation studies on ampoule & vial machines.
1.5 All LAFs and Pass boxes Qualification.
1.6 Steam quality test Qualification.
1.7 compressed air quality test qualification.
1.8 All AHUs and its Qualification in coordination with engineering department.
1.9 Thermal qualification for tunnel machine.
1.10 Equipment Qualification.
1.11 Monitoring all external activities done by the outsource and archive reports.
2. Participate in SOPs creation and revising.
3. Any Other tasks within scope of validation department duties assigned by validation section head.
4. Prepare the Validation calendar Plan and index Annually, validation protocols and reports.
5. Prepare Validation Master Plan.
6. Responsible for calibration, monitoring and reporting of the following:
6.1 Balances Pressure Gauges and transmitters.
6.2 Temperature Sensors.
6.3 QA Devices.
6.4 Conductivity Meters.
6.5 Thermohydrometer calibration.
Qualifications :
Fresh can apply to 3 years Exp. ( Fresh 1st priority )
Computer System Validation, Process Validation, and Validation skills
Experience in Quality Control and Quality Assurance
Attention to detail and strong analytical skills
Knowledge of regulatory standards in the pharmaceutical industry
Ability to work effectively in a team environment
Bachelor's degree in Pharmacy, Chemistry, or related field
Certifications in validation processes are a plus
- If you are interested, Please send your CV with Subject " Validation Specialist " to N. : 01010083175 or Email : mohamed.alaa@henfypharmagroup.com