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Develop phase-appropriate QC capabilities, business processes, and procedures to ensure robust product supply, including establishment of appropriate processes for specifications setting and holistic...
Ensure that Complaint Investigations and records of Servicing activities are thorough, accurate, self-explanatory, and completed in a timely manner into the complaint handling system...
Experience in implementation of an Enterprise Resource Planning (ERP) solution, electronic Document Management System (eDMS), electronic Learning Management System (eLMS), electronic CAPA solutions an...
Develop, implement, maintain, and continually assess the Company’s QC function and Quality Management System (QMS) for applicable regulated activities to meet internal company standards and external g...
Dispositions drug substance\drug product batches and work-in-process materials for use in downstream manufacturing operations, dispositions final products for clinical or commercial use. Provides appr...
Understand practical applications of GMP phased approach and a risk bases Quality approach; write and update existing procedural documents to incorporate these approaches, Responsible for reviewing, t...
Work with Senior Leadership and cross-functionally to establish strategies, priorities and goals for risk management, failure analysis, process validation, process reliability, trend analysis, statist...
A successful candidate in this role will be responsible for leading analytical method development, validation, test method transfers to QC labs, initiation on internal QC testing at, and stability ev...
They will have projects and tasks from product inception through launch and maintenance and play an active role in processes to make sure products meet quality standards with corporate and business un...
Oversees a team and provide guidance and mentoring to ensure investigation best-practices are implemented and utilized during complaint investigations of infusion pumps. Performs other related duties...
Designs, implements, and maintains complaint investigation processes and procedures, including writing requirements and process documentation.Ability to solve complex problems by developing novel fail...