Quality Assurance Manager
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Key Responsibilities
Manage and maintain quality documents within the eQMS platform Scilife, including: -Training administration and follow-up -User support and helpdesk activities -Document lifecycle management -Force reviews and periodic reviews -Document & training exports and archival activities -Management of obsolete documents Review and support quality documentation related to: -Clinical operations activities -Internal audits Manage and coordinate deviations related to clinical operations and audit activities, including investigation support, root cause analysis, CAPA follow-up, and effectiveness verification. Provide Quality Assurance support and guidance to Clinical Operations to ensure compliance with applicable GCP and internal quality requirements. Contribute to IT validation activities (approximately 10% of workload), including documentation review, validation support, and compliance oversight. Participate in continuous improvement initiatives and support inspection and audit readiness activities. Key
Skills:
Quality Management Systems (QMS) Scilife Administration and Document Control In-depth knowledge of GCP Deviation and CAPA Management Internal Auditing IT Validation (CSV) is a plus Document Management and Training Systems
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