Risk Assessment Jobs in Holly Springs (NC)
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Search Results - Risk Assessment Jobs in Holly Springs (NC)
Insight Global-Holly Springs (NC)
RTM), Quality Risk Assessment (QRA), Site Acceptance Testing (SAT), Installation Qualification, Operational Qualification, Performance Qualification, including Final Reports.
• Plan, develop, and execute commissioning, qualification, and validation...
mindmatch.ai -
Holly Springs (NC)
and scientific guidelines (e.g. ICH, EMA, FDA, etc.)
• Supports regulatory requests and inspections
• Supports the QCAD team to investigate any project challenges with necessary risk assessment tools and techniques
• Supports best practices for TT and PPQ...
icims.com -
PharmEng Technology-Holly Springs (NC)
pharmaceutical facilities and equipment.
• Conduct risk assessments and gap analyses to identify potential compliance issues and develop strategies to mitigate them.
• Lead and manage CQV project teams, including coordinating with internal and external...
resume-library.com -
Holly Springs (NC)
Leads technical risk assessments for new manufacturing processes
• Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification
• Writes...
icims.com -
Holly Springs (NC)
QA) review and approval of exceptions and CAPAs, while also facilitating the timely review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols and reports, risk assessments, changeover...
icims.com -
Holly Springs (NC)
assessments and quality risk assessments for process equipment
• Performs technology transfer (TT) activities related to process equipment
• Supports execution of Good Manufacturing Practices (GMP) runs
• Provides technical support for root cause analysis...
icims.com -
Holly Springs (NC)
Leads technical risk assessments for new manufacturing processes
• Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification
• Writes...
icims.com -
Holly Springs (NC)
ICH, EMA, FDA, etc.)
• Supports regulatory requests and inspections
• Supports the QCAD team to investigate any project challenges with necessary risk assessment tools and techniques, as needed
• Supports best practices for TT and PPQ strategies...
icims.com -
Holly Springs (NC)
to critical deviations, as needed
• Serves as subject matter expert (SME) to support TT stage gate reviews on incoming processes for manufacturing readiness (e.g., acceptable process characterization and validation, risk assessments, mitigation, and robust...
icims.com -
Holly Springs (NC)
Supports regulatory requests and inspections.
• Supports the QC AD team to investigate any project challenges with necessary risk assessment tools and techniques, as needed.
• Supports best practices for TT and PPQ strategies globally, as required...
icims.com -
Holly Springs (NC)
and standard operating procedures (SOPs), as needed
• Supports technical risk assessments for new manufacturing processes
• Supports collection and interpretation of manufacturing data and process monitoring
• Provides on-floor manufacturing support throughout...
icims.com -
Holly Springs (NC)
and performs risk and gap assessments during project scoping
• Develops project plans that align with program scope and customer expectations
• Ensures the analytical team understands business goals and customer expectations and delivers results according...
icims.com -
Holly Springs (NC)
and approves P&IDs and other technical documents as the technical authority
• Leads system impact assessments and quality risk assessments for process equipment
• Performs technology transfer (TT) activities related to process equipment
• Supports execution...
icims.com -
Holly Springs (NC)
risk assessments and developing mitigation strategies
• Training and/or familiarity with Quality Risk Management principles
Working Conditions & Physical Requirements
• Ability to discern audible cues
• Ability to stand for prolonged periods of time...
icims.com -
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