Participating in: GMP Projects, Different Validation Working Parties.
Checking and follow up the site validation review plans for (building, HVAC system, services and equipment).
Prepare, review and update the Validation Master Plans (VMP),design qualification , installation Qualification & operation Qualification and Performance Qualification Protocols (PQPs) and Validation reports (VR) for different validation activities such as:
Process validation.
Cleaning validation.
Validation Review.
Facility Qualification.
Thermal Mapping.
Media fill.
Internal & External Calibration.
Internal & External Qualification.
Annual product quality review (APQR).
Water System Performance Qualification Protocol and report (phase 1, phase 2).
Holding Time for Pharmaceuticals during Manufacturing Process.
Skip Testing Pharmaceutical Industry Validation Protocol & Report.??????????
up the following activities to review and approve them:
Receiving all calibration certificates, follow its approval and filing.
Filing all validation deliverables and retrieving them professionally.
Review and approved for all Qualification report.
Review and approved for all Calibration report.
Review for all new batch production record.?
Review for all new standard operating procedure related the validation section.
Review for all new standard formulas. ??
Following up closing of change control incomplete implementation requirements concerning validation activities.
Ensures that all activities in his unit or section are done according the relevant cGMP and ISO standards (ISO 9001, ISO 14001, OHSAS 18001)
