Cellares
pharmaceutical, biologics, vaccines, cell or gene therapy
SeniorQualityValidationSpecialist
“Senior Quality Validation Specialist at Cellares. Skills: Quality Validation, GMP Operations, Regulatory Compliance. Review and approve documentation. Author and maintain Site Validation Plan”
What You'll Achieve.
increase efficiency; increase productivity; accelerate drug development; scale out manufacturing; lower process failure rates; lower manufacturing costs; meet global patient demand
Industry & Context.
resolve technical issues; resolve compliance issues
What They're Looking For.
Must Have
Bachelor’s degree in a scientific or engineering discipline, 5 to 8 years of experience in a GMP environment, 2+ years of direct experience in quality or validation, knowledge of relevant cGMP regulations, knowledge of current Good Manufacturing Practices (GMP), Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products, Quality by Design approaches, Excellent understanding of risk management and CAPA processes, Ability to understand and interpret complex scientific issues
Nice to Have
experience with on-site regulatory inspections is desirable, Experience with computerized systems validation (CSV) is a plus
What You'll Do.
Review and approve documentation
Author and maintain Site Validation Plan
Provide Quality oversight
Provide oversight of cleanroom lifecycle programs
Proactively identify & resolve issues/gaps
Ensure adherence to procedures
Act as Quality Engineering SME
How You'll Work.
Team & Collaboration
Collaborate with stakeholders; communicate progress; issue status reports
Applying for this Senior Quality Validation Specialist role?
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