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Associate Director of PTO

hace 2 meses

Xico, México Organon A tiempo completo

Job Summary

The Associate Director of PTO is a key leadership role responsible for managing the technical support to the manufacturing and packaging areas of the site, ensuring compliance and implementation of local regulations and corporate standards regarding Validation and Qualification.

Key Responsibilities

  • Define and implement plans and strategies for continuous improvement throughout the product supply chain.
  • Provide technical support necessary for problem solving, defining corrective and preventive actions to avoid recurrence in order to ensure compliance with production, quality, safety and financial goals.
  • Collaborate in a cross-functional manner with members of your team and other areas to achieve business objectives.
  • Identify, prioritize, promote, and execute continuous improvement projects in order to make areas of opportunity in processes and equipment more efficient that result in cost savings, time and efficiency in strict compliance with quality and regulatory requirements.
  • Ensure timely compliance with activities within its scope of competence that affect the supply of batches such as: Exchange Controls, Deviations, Protocols and Reports, Records, Risk Analysis, among others focused on maintaining the pace and adherence to the production plan.
  • Participate in the planning of activities by scheduling the necessary times and resources for the execution of the different technical studies within the plant.
  • Be responsible for the liaison of the IPT and its requirements with the COE of Technical Operations, ensuring effective and timely communication as well as a quick solution and effective decision making according to the need.
  • Actively participate according to the frequency established in the TIERS to provide support and/or solve technical requirements.
  • Promote continuous improvement, seeking and sharing information on best practices implemented in other Organon plants.
  • Collaborate in the standardization of the work of the lines.
  • Support with resources in the resolution of technical problems in the plant, both processes and equipment, to guarantee the continuity of operations.

Quality and Safety

  • Promote a culture of quality within the IPT and production lines, proactively supporting the site to be ready at a moment's notice for a regulatory inspection.
  • Participate within the IPT by making the members aware of the standards and technical strategies implemented at the IPT level.
  • Promote improvements in quality and safety, seeking and sharing information on best practices implemented in other Organon plants.
  • Promote safety, health, and environmental protection, positively and constructively reinforcing the members of its collaborative team and the IPT.
  • Take the lead of technical research related to processes/equipment.
  • Ensure the participation of a member of your team in investigations of outliers/deviations that have a technical component.
  • Be responsible for equipment qualification activities and respective process validation activities.
  • Collaborate, evaluate, and technically approve change implementation activities for teams and processes.
  • Verify the manufacturing and conditioning records of a technical nature, evaluating that they are within the validated parameters.
  • Maintain the procedures and guidelines corresponding to their role.
  • Be responsible for the administration of the documentation generated for all the tests of Validation and Qualification studies, as well as any other of a technical nature within its scope of competence.
  • Establish action plans to mitigate the quality metric(s) under his/her responsibility that are out of trend.

Training, Coaching, and Administration

  • The Technical Leader regularly attends productive areas to observe, learn, talk to people, and provide feedback.
  • Collaborate by training staff and sharing knowledge for the correct understanding and use of equipment, systems, and processes to ensure effective operations.
  • Provide technical training and coaching to operators, production coaches and mechanics and/or whoever required to ensure that technical knowledge is transmitted to the members of the IPT.
  • Provide ongoing education to promote a culture of continuous improvement and sponsors a safe environment for giving and receiving feedback.
  • Discuss mistakes and opportunities with their direct reports to share learning.
  • Motivate, develop, coach, and advise staff to solve situations on their own.
  • Prepare and ensure compliance with the annual budget of your area.

Requirements

  • Comply with NOM-059-SSA1 Good Drug Manufacturing Practices and applicable health regulations.