Sr Associate QA (Lims)

Will assist with document review and initiate incidents, as well as coordinate and compile general documents and oversee room clearance inspection.; Skills: ; quality assurance or manufacturing experience in the pharmaceutical or medical device industry

• Responsible for SM LIMS data coordination activities, including sample reconciliation and CoA generation.
• Responsible for management of SM LIMS approval based tasks; aligned to source documentation.
• Responsible for supporting validation activities for SM LIMS and associated quality document management.
• Responsible for data queries from QC’s electronic systems.
• Responsible for QC Assessor for Change Controls impacting analytical systems.
• Provides ownership and QA oversight for document management of various processes within QC.
• Comply with safety guidelines, cGMPs and other applicable regulatory requirements.
• Supports inspection readiness activities across Quality Control, and site audits and inspections.
• Maintains project plan commitments supporting critical projects
• Supports Continual Improvement initiatives, programs and projects.