Job
Description
Role & responsibilities Responsible for processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow. This includes but is not limited to SOPs, production records, test methods, specifications, protocols, reports, equipment, processes, material suppliers, facilities, computer systems etc. Responsible for review and approval of all continual improvement projects affecting quality at a site Responsible for processing of documents through the generation, modification, review, and approval workflow. This includes but is not limited to SOPs, production records, test methods, protocols, reports, labeling, etc. also, archival of records Responsible for Review of regulatory and quality compliance requirements and divisional policy, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability. Development and monitoring of corrective action plans where needed Ensuring quality support to regulatory affairs as it relates to updates/changes to market authorizations Review of all documentation (i.e. LIR, OOS, Change Controls, etc.) Ensuring quality interface with internal and external customers when dealing with activities such as service requests, issue resolution, complaints, product information, or for movement of materials, products, or process from site to site Responsible for management of regulatory authority and other external compliance audits (e.g. Customer audits) including communication, tracking and resolution of observations. Management of communications with regulatory agencies including required reporting and resolution of any actions required by the agencies Responsible for Performing, reporting of observations and verification of compliance reports of internal audit
