Project Quality Lead - 9 month FTC
Core
Lead quality planning and validation documentation review for a major capital project build in a pharmaceutical and life science manufacturing facility.
Role type
Project Quality Lead
Builds
New manufacturing facility validation and qualification strategies
Domain
Life sciences / Pharmaceutical manufacturing / Quality Assurance
Deliverable
client delivery
Required skills
Validation documentation review, Quality risk assessment, Process qualification strategy, Engineering document approval, Stakeholder alignment, Quality metrics reporting
Preferred skills
cGMP knowledge, ISO9001 experience, Equipment/process/cleaning validation, QMS software (Q-Pulse)
Technologies
Microsoft Office, Q-Pulse
Responsibilities
Lead creation of Project Quality plan for capital project, Review and approve engineering validation documents, Partner with engineers to develop CQV strategy, Develop Process Qualification and Validation Strategies, Establish and report quality metrics, Ensure document approval timelines
Seniority
Mid-level, hands-on IC
