• 5 years of experience in any of the following: Process, Equipment, Computer,
Utilities, Cleaning Validation and Change Controls.
• Knowledge of cGMPs, FDA and other Regulatory requirements.
Bachelor's Degree, preferably in Physical Science or Engineering
Prior Experience with:
- process validation
- auditing documentation for compliance
- participation on EI teams
Provide quality oversight for process, equipment, utilities and cleaning validation projects. Review and approve validation protocols. Manage change controls.•
Review and approve all Process, Equipment, Cleaning and Utilities Validation Protocols for compliance to internal
Process Validation Program requirements.
• Review and approve all Process, Equipment, Cleaning and Utilities Engineering Validation Quality/Deviation
Assessments for impact to the state of Process Validation.
• Participate on EI Teams as required to provide QA Validation Impact Assessments and Compliance guidance.
• Review and approve all Critical Documents, Critical Change Control Requests/Assessments for impact to the state of
Process, Equipment, Cleaning and Utilities Validation, as well as site compliance.
• Periodically audit all Process, Equipment, Cleaning and Utilities Engineering Validation documentation for compliance
to all internal/external Regulatory Policies and Guidelines (cGMP's, SOP's, NDA's, GQP/G's, Technical Dossiers,
• Prepare and report all Process, Equipment, Cleaning and Utilities Engineering Validation audits through PPR's,
Validation Periodic Reviews, etc.
• Participate in teams to present Product QA and Process, Equipment, Cleaning and Utilities Engineering Validation
documentation during Internal and External Regulatory inspections and prepare responses to deficiency reports.
• Review and coordinate Change Controls.
You may apply for this position online by selecting the Apply now button.
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