Attend Implementation & Follow-Up results of all Validation & Qualification
activities (Process Validation – Cleaning Validation – Holding Time –
Performance Qualification- CSV) 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
relative protocols & reports prepared by subordinates, other departments or
external 3rd parties to ensure their compliance with the section’s specified
3rd parties service providers upon needed to perform any Validation &
Qualification activities to assure smooth running of the planned activities.
Section’s Standard Operating Procedure & review relative ones to assure
their compliance to required standards/regulations.
in investigations in case of any OOSs occurred during or after implementation
of validation or qualification activities to reach the root cause to help judge
the validity of the performed activity.
required risk assessments to study cause/ impact of an event and make sure the
required control measures are adequate to reduce/ eliminate associated risk.
organize & follow-up Validation & Qualification tasks with Validation
& Qualification Specialist and supervise their work to assure the
correctness, orderly and timely completion of their tasks.
section’s lead with all assigned tasks to facilitate judging of the plans’
compliance & monitor efficiency and effectiveness of implementation of
& 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.
the completion of all change control actions within due dates & its
effectiveness to the system, to maintain adequate control.