Quality Assurance Compliance Specialist, Change Control
Core
Ensure quality and compliance with cGMPs and regulatory requirements for change control activities in a pharmaceutical fill finish facility.
Role type
Quality Assurance Compliance Specialist (Change Control)
Builds
Change control documentation and processes for pharmaceutical manufacturing
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
cGMP knowledge, FDA regulations, ICH guidelines, global regulatory compliance, change control documentation review, cross-functional collaboration, process improvement, regulatory audit support, Microsoft Office proficiency
Preferred skills
Process Compliance/QUMAS experience, change control function experience
Responsibilities
Reviewing and approving change control documentation, facilitating cross-functional meetings, developing relationships with end users, partnering on continuous improvements, interpreting compliance requirements, supporting regulatory audits
