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We are searching the best talent for Quality Supervisor LAN - Director Tecnico to be in Bogota, Colombia.
Purpose: Coordinate, implement and maintain the standard and local regulations related to warehouse and transportation processes. Lead the release process to ensure the correct disposal of the product trough the correct execution of the process defined and the alignment with all the areas related to the process. Provide timely and effective support to the Deliver team regarding operations, to ensure Quality controls in the storage, conditioning, and distribution process, as well as the logistics service levels of the company. Connect with the areas related to the core of processes at the warehouse and transportation to define strategies to guarantee the accomplishment of the standard and regulation required
You will be responsible for :
• Responsible for assuring the product inspection and disposition during the inbound process
• Responsible for products release, ensuring their correct disposition
• Guarantee the physical inspection of the products according to what is established by the local regulations of each country, during importation, after R&R process and during reception of product return. In the case of controlled substances, their respective handling must be considered.
• Review and approve quality issues documented for deviations related to the process under commercial quality deliver responsibility
• Guarantee product physical ubication of the product at the correct status
• Review products release metric management ensuring that they are done properly and within the established times.
• Stop Shipments, Recalls, Field Actions, disposition follow up; to ensure that they are done within the time and following the established procedures.
• Actively participate in the initiatives of the Commercial Quality team to ensure continuous improvement of logistics operators.
• Provide support to the implementation and maturity of the Pharma quality management system, including handling-storage & distribution program, supporting the closure of CAPA's, Non-Conformities, Change Controls, and ensuring the correct implementation of the other fundamentals
• Guarantee compliance with the Repack & relabel standard in the country, evaluating the final disposal of the relevant products and / or conditioning materials in accordance with what is locally approved.
• Support labeling process guaranteeing the process of materials and product verification
• Lead product retention management process at the warehouse
• Support other areas in the investigation process of their deviations, deliver and customer service
• Lead 3pl surveillance
• Lead BID´s with information requested for Quality
• Lead the reception of Health Authority Inspections in LOC and at the warehouse.
• Lead the reception of customer audits
• Lead visits from customers
• Follow up to Gemba Walk results according to the schedule defined in each country, including the follow up and action plan status
• Manage operation 3PL license requirements
• SME of the temperature control program
• Lead strategies for processes related to the Storage and Distribution of products with Temperature Control.
• Lead implementation of local projects
• Support Temperature Control Standard (Cold chain qualification, Room’s qualification, Facility mapping)
• Lead divestiture & acquisitions
• Guarantee the implementation and correct maintenance of the controlled substances process
• Participate in the readiness and execution of the internal audits (BRQC, JJRC) being responsible also for the proposal of the activity plan, the implementation and follow up
• Identify and notify the possible escalation deviations
• Supervise 3PL activities to assure the compliance of local regulation and Janssen standards
• Review and approved monthly 3pl metrics, follow up of the action plans related to those
• Responsible for the CEMS licenses administration
• Lead the NPI & launches excellence & delisting process
• Lead the GXP Audit & Inspection management process
• Support Product development process
• Guarantee local tests for product in Peru
• Support the execution of training for 3PL in Peru
• Support the readiness for local certifications in Peru
• Support the self-inspection process in Perú
• Develop and get the approval of Quality agreements with the suppliers for the operational process
• Focal point with manufacturers
• Focal point with health authorities when applicable
Qualifications and requirements:
- Bachelor degree QFB
- Minimun 8 years of experience
- Experience in pharmaceutical industry
- Bilingual english
- Organization, planning, and coordination of projects
- Attention to detail and adherence to procedures