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Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Bogotá, Distrito Capital, Colombia

Job Description:

Responsible for coordinating the implementation of the processes related to the product handling, storage, and distribution. Lead and support the products release, ensuring their correct disposal by requesting the logistics operators for evidence of physical segregation, within the times established for each country.

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.

Essential duties and responsibilities:

• Responsible for assuring the product inspection and disposition during the inbound process for Colombia an Ecuador.
• Responsible for products release, ensuring their correct disposition by requesting evidence of physical segregation from logistics operators, within the times established for each country. The foregoing also applies to the handling of controlled substances.
• Lead and actively participate in audits of Third-Party Logistics (3PL) providers and suppliers, ensuring strict adherence to Johnson & Johnson's quality standards and regulatory requirements. Foster a culture of compliance and continuous improvement to enhance operational excellence.
• Generate quality issues to document any deviation related to the process under Commercial Quality delivery responsibility, ensuring that all discrepancies are thoroughly analyzed and addressed to maintain high-quality standards.
• Guarantee product physical ubication of the product at the correct status.
• Products release metric management and follow up; 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 through verification of materials and product and reporting any deviation identified to the LOC commercial team.
• Lead product retention management process at the warehouse.
• Support other areas in the investigation process of their deviations, Deliver and customer service
• Spearhead the oversight of Third-Party Logistics (3PL) processes, including the surveillance of non-conformities and performance metrics.
• Drive the implementation of operational projects within the Colombian warehouse aimed at optimizing efficiency, reducing costs, and minimizing processing times. Support BID´s with technical information
• Lead and support the reception of customer audits
• Support visits from customers
• Lead and support Gemba Walk according to the schedule defined in each country, including the follow up of the action plan
• Manage operation 3PL license requirements
• SME of the processes executed in SAP
• SME of the temperature control program
• Support processes related to the Storage and Distribution of products with Temperature Control.
• Support or lead implementation of local projects
• Lead and support Temperature Control Standard (Cold chain qualification, Room’s qualification, Facility mapping, passive solutions and active solutions)
• Support divestiture & acquisitions
• 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
• Support the reception of Health Authority Inspections in LOC and at the warehouse.
• Assurance compliance with BPM practices
• Guarantee the quality of all products marketed in J&J for Colombia, as well as their regulatory compliance.
• Liaise with academic institutions and government organizations to encourage collaboration on policy changes.
• Ensure annual training of defined suppliers (3PL)
• Lead the preparation of self-inspection process and/or internal audits to comply with local regulation.
• Cross Sector process support as appropriate, keeping the Medical Technical Department informed.
• Open the inventory movement log through a signed record by the legal representative.
• Assurance of the monthly controlled substances report to the CAN.
• Responsible for assuring compliance of controlled substances process (Handling, storage, distribution and destruction) correctly implemented and review compliance of the standard at the warehouse and process related.
• Participate in the development of procedures related to the storage, packaging, dispatch, and distribution of controlled substances, in accordance with the instructions documented in the quality agreement with the logistics operator.
• Verify the usage decisions of controlled medications: imported, packaged, returned, rejected, or counterfeit, and their release in accordance with the respective documentation.
• Verify the return of quotas, as applicable, and ensure timely notification to the CN

​Requirements

• Minimum: Professional in the pharmaceutical area, with work experience in the pharmaceutical / biotechnology industry with extensive experience in quality assurance, process methodology.
• Work Experience | 2-3 years
• SAP Knowledge
• Nonconformity system
• English: Intermediate/advance level

Special requirements:

• Strong verbal and written communication skills
• Adaptation to change
• Ability to carry out responsibilities, with an acceptable level of supervision.
• Can carry out responsibilities and teach others
• Technical Expertise in Quality Assurance (KNOWLEDGE)
• Strategic thinking to support the regulatory plan through data analysis, synthesis, and integration (STRATEGY)
• Attention to detail and adherence to procedures (COMPLIANCE)
• Customer-oriented mentality with staff of internal and external interest through interactions that add value (PERSPECTIVE AND COLLABORATION)
• Influence, negotiation and strong verbal and written communication skills (COMMUNICATION)
• Innovation, challenge, and adaptation to change (INNOVATION)
• Organization, planning and coordination of projects
• SAP Knowledge

 

 

Required Skills:

 

 

Preferred Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing