Preparing, Implementing & Following-Up results of all Validation & Qualification activities according to written procedures with the required guidance of standards/ regulation.
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.
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.
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.
Bachelor’s Degree in Pharmacy or science or Engineering (Mechanic or Chemical )
Experienced in QA or QC are perferred
Years of Experience:
17 March 2022
Application End Date:
17 April 2022
QA - Validation