Quality R&D Site Specialist
Core
Provide Quality Assurance support for the establishment, qualification, and ongoing oversight of the Global Oral Health Scale Up Facility (GOHSU) to ensure compliance with GMP and support product scale-up.
Role type
Quality R&D Site Specialist (GMP/Regulatory)
Builds
Oral Health products (Sensodyne, Panadol, etc.)
Domain
Consumer Healthcare / Oral Care / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, Quality Management Systems, Change Controls, Deviation Investigations, Equipment Qualification, Validation, Audit Management, Regulatory Documentation, Cross-functional Collaboration
Preferred skills
Experience with oral care/medical device regulations, Electronic QMS (Veeva), Method Transfers, Cleaning Validation
Technologies
Veeva QMS, MS Office Suite
Responsibilities
Guide and approve qualification and validation activities for systems, equipment, and facilities; Provide QA oversight for Change Controls, Deviations, and Laboratory Investigations; Review and approve quality documentation including GMP procedures and reports; Perform final QA release activities for materials and products; Support third-party management and supplier quality interactions; Participate in internal and external audits and inspections; Contribute to the development and implementation of local and global SOPs.
Seniority
Mid-level (3-5 years experience)
