Senior Quality Assurance Specialist

The Snr. Commercial Quality Specialist is responsible for the quality of, and meeting the applicable requirements for, the products that the LOC markets, or the products that it produces for other companies (including all named-patient materials, product samples and/or clinical supplies). He/she is also responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GMP/GDP activities the LOC undertakes. In this role he/she has defined authority and responsibility for ensuring that quality system and processes are implemented and maintained according to Quality Manual and J&J Quality Management System. MAIN ACTIVITIES/TASKS: Quality Systems Implement the Quality System via transposition of the requirements of the Commercial Quality Manual (CQM) and J&J Quality Management System. Prepare, update and approve LOC procedures in accordance with local GMP/GDP, CQM and J&J requirements. Execute minimum requirements regarding lifecycle management of GMP/GDP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity. Ensure the provision of appropriate training for all job functions with GMP/GDP responsibilities. Ensure appropriate internal and external change control systems are in place and are followed. manage the preparation, execution and follow up for external inspections, and report these and any other relevant field action activity into the CURVE. Monitor quality system performance versus local GMP/GDP, CQM and J&J requirements via use of pertinent business and compliance metrics and goals. Drive continuous improvement in the Quality System using quality system performance information, in conjunction via periodic internal audits, deviation management, CAPA management and performance reviews. Notify and engage LOC Quality Head and Commercial Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in CQM. Quality Processes Ensure an effective procedure and adequate system to handle product and PQC complaints, escalate critical product issues and conduct recalls and other field actions in a timely manner (including outside business hours, plus COMMERCIAL QUALITY HEAD backup in every case of absence). Ensure suppliers of any critical materials (all product related suplliers & services) are qualified and periodically audited against company & local GMP standards. Examines the regulations / procedures of the Ministry of Health in line with company strategies, ensures compliance with them and undertakes the responsibility for them. Manages the product and service supplier processes within the scope of Quality requirements. Ensures supplier qualification, organizes, and conducts inspections and participates. Ensures that the procedures related to the quality system are prepared, updated, and trained in accordance with Janssen International Quality System Guidelines,