Quality Systems Specialist
Core
Develop and implement site Quality Systems to support the manufacture and release of Combination products, including SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification & management, material and batch disposition, complaints and annual product review.
Role type
Quality Systems Specialist
Builds
Combination products (inhalation dosage forms)
Domain
Healthcare / Pharmaceutical Manufacturing
Required skills
Quality Systems design and implementation, SOP development, document control, change control, investigations, CAPA management, internal auditing, Vendor qualification, material and batch disposition, complaint handling, annual product review, EU & US regulatory compliance, Trackwise, SAP, Microsoft Office suite
Preferred skills
Inhalation dosage forms experience, start-up experience, continuous improvement program leadership
Responsibilities
Develop and implement site Quality Systems, Provide QA support for Inspection Readiness, Collaborate with Engineering, Validation, Manufacturing, Regulatory and Global Quality, Support operation of the site Training system, Ensure compliance with regulatory guidance documents, Drive improvements in product and process quality, Comply with Health and Safety Requirements
Seniority
Mid-level, hands-on IC
