Senior Quality Assurance Specialist (External manufacturing)
Core
Oversee and ensure quality compliance of external manufacturing partners (CMOs) through quality agreement management, audits, product transfers, CAPA follow-up, and technical complaint resolution.
Role type
Senior Quality Assurance Specialist (External Manufacturing)
Builds
Ensures adherence to cGMP standards and regulatory requirements for third-party manufacturing operations.
Domain
Biopharmaceutical manufacturing / Quality Assurance
Deliverable
client delivery
Required skills
Quality agreement management, CAPA implementation, cGMP compliance, audit management, product transfer qualification, validation, root cause analysis, risk assessment, stakeholder coordination, documentation review
Preferred skills
Sterile manufacturing experience, QA auditing, validation and qualification expertise
Technologies
MS Word, Excel, PowerPoint
Responsibilities
Prepare and follow up on quality agreements with manufacturing subcontractors; conduct gap analysis for CMOs management global guidelines; perform final release of toll out products; lead qualification & validation activities during product transfer projects; investigate customer complaints at CMO level; participate in quality risk management and risk assessments; support regulatory inspections at external manufacturing sites.
Seniority
Senior, hands-on IC
