Katalyst Healthcares and Life Sciences
Responsibilities:
- Local Validation Program Maintenance.
- QAV Documentation Review and Approvals for local and CMO's.
- CS Periodic Reviews planning and approvals.
- QA GMP IT Support for DI and CS INF activities.
- Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation).
- QRFR's Generation.
- Metrology Deliverables Review & Approval (forms or SOP's) + SAP Operation.
- SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective.
- Validated Equipment Requalification, Modification/ Remediation/ Decommissioning.
- Software Upgrade(s).
- Validation SME support for QMS Impact Assessments and Change Actions.
- Validation Support for Risk Assessment on Equipment.
- dHOC Validation Support on Global Computerized Equipment Deployment.
- Serve as liaison and cross-functional lead with department likes QC, Manufacturing and Quality Assurance to provide an overall compliant Validation and QAV program with Client standards and GMP regulations.
- The role will support the Validation, Metrology and QAV department in drafting, reviewing, approving documentation in conjunction with Client guidelines.
- URS.
- Registration/ Calibration form.
- SCCA forms.
- Risk Assessment (for equipment with CSV).
- Configuration Spec. (for equipment with CSV or as applicable).
- Vendor qualification package (if purchased).
- Global/Digital CS System QAV Representation and deliverables approver.
- Internal Validation protocol.
- Requirements Traceability Matrix.
- Internal Final Report.
- Reports will be provided within client Quality Management System and email.
- Reports to channel through Quality Assurance Validation staff.
- Engineer or related BSc/BEng degree.
- Previous Pharma Experience required.
- Previous QA Validation experience Required.
- Minimum 10-15 years of experience.
- Previous experience supporting a Business System Owners on their GMP Manufacturing and Lab Equipment as well as supporting Corporate/Global Computerized Systems and manufacturing.
- Previous experience QAV department in drafting, reviewing, approving documentation.