Validation Senior Specialist - Alexandria

• Prepare Attend Implementation & Follow-Up results of all validation & Qualification activities (Process Validation – Cleaning Validation – Holding Time-Performance Qualification) performed within all technical departments – within 3 shifts & for overtime periods whenever required – which includes preparing the required protocols & reports, starting from the draft copy till getting their final approval to comply with the specified relative plans in VMP.
• Review Installation & Operational Qualification activities documents to assure their compliance to c-GMP & required standards/regulations.
• Review Annual trend reports of environmental monitoring, water systems & compressed air use points, to finally prepare an annual final report for each activity to comply with the performance qualification plan of utilities.
• Share in investigations in case of any OOSs occurred during or after implementation of validations or qualification activities to reach the root cause to help judge the validity of the performed activity.
• Feedback Validation & Qualification Lead with all assigned tasks’ updated on daily basis , in addition to a weekly written reporting system of the week’s planned & unplanned tasks to facilitate judging of the plans’ compliance & monitor efficiency and effectiveness of implementation of assigned tasks.
• Assess & evaluate any change on an established standard, validated, qualified or controlled system affecting technical operation in the company to assure the system remains controlled in a validated state.
• Follow-up the completion of all change control actions within due dates & its effectiveness to the system, to maintain adequate control.

job requirements

3 to 6 years

Not Specified