Validation Section Head
Rameda -
6th of October, GizaPosted 2 years ago18Applicants for1 open position
- 4Viewed
- 0In Consideration
- 14Not Selected
Job Details
Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:
Skills And Tools:
Job Description
- 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 QA Manager) that all validation activities and documentation are complying with the recommendations of guidelines as well as VMPs and product master file.
- 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.
- 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 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.
- Participate Suppliers Qualification.
- Ensures that all activities in his unit or section are done according the relevant cGMP and ISO standards (ISO 9001, ISO 14001, ISO 45001)
- Follow up validation activities with all validation members.
Job Requirements
- 8-10 years of experience
- Bachelor degree of pharmacy or Science