QA Operations Officer
Core
Ensure product quality in manufacturing by monitoring operations, reviewing batch records, and managing deviations and changes.
Role type
QA Operations Officer
Builds
Manufacturing batch releases and compliant product quality systems
Domain
Healthcare / Pharma Manufacturing
Required skills
Good Manufacturing Practices (GMP), Quality Risk Management, stability study review, deviation investigation, batch record review, regulatory compliance (EU/US), Microsoft Office suite, electronic database systems (Trackwise, SAP)
Preferred skills
Inhalation dosage form experience, quality system design, start-up experience
Responsibilities
Collaborate with manufacturing and engineering to drive quality awareness; Monitor key quality indicators and manufacturing operations; Review and evaluate batch records for product disposition; Participate in deviations, changes, self-inspections, and Product Quality Reviews.
Seniority
Mid-level, hands-on IC
