To Collects data and technical writing of all Validation & Qualification (URS, Process, Cleaning, Holding time, Equipment qualification, Computer system validation, Thermal Mapping) documents according to written and approved procedures to ensure that all procedures are up to EDA standards and regulations.
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
Installation & Operational Qualification activities documents to assure
their compliance to cGMP & required standards/regulations.
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
validation or qualification activities to reach the root cause to help judge
the validity of the performed activity.
Validation & Qualification Lead with all assigned tasks’ updates 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.
•Education: B.Sc. of
Science OR Phrmacy.
and Team player with high attention to details.
planner and Logical Thinker.
•Excellent command of
resident and males only .
Years of Experience:
24 August 2023
Application End Date:
24 September 2023
QA - Validation