- Participating in: GMP Projects, Different Validation Working Parties.
- Checking and follow up the site validation review plans for (building, HVAC system, services and equipment).
- Ensuring (under direct supervision of validation section head) that all validation activities and documentation are complying with the recommendations of guidelines as well as VMPs and product master file.
- Share in preparing 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.
- Thermal Mapping.
- Media fill.
- Internal & External Calibration.
- Internal & External Qualification.
- Annual product quality review (APQR).
- Holding Time for Pharmaceuticals during Manufacturing Process.
- Following 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 for all new standard operating procedure related the validation section.
1-3 years of experienceBachelor degree of pharmacy or Science