New Material Introduction Coordinator

PROCHEM Engineering Limited

Carlow

Role Summary: The successful candidate will work within the supply chain Materials and SAP team at our client’s busy pharmaceutical site in Co. Carlow. They will be responsible for the material management Process. Primary responsibility will be for the management and co-ordination of New Material Introduction (NMI) Process. Contributing to the site clinical and commercial New Product Introduction program, dual sourcing initiative and supporting supplier and material changes for the site. Site cross-functional collaboration and supplier interaction is required to support this process. Material management process also includes the management of supplier change notifications and supplier and sister site complaints. Ensure that objectives are effectively achieved, consistent with Company requirements to ensure compliance, safety and reliable supply to their customers.  Core Duties and Responsibilities:  Responsible for completion of the Material introduction process ensuring that all suppliers and materials are approved for use on site in compliance with site and Global procedures. This includes the creation and maintenance of Approved Material files including Material Specification. and purchasing and distribution documentation as required. Assist in changes to existing materials or suppliers on site and the implementation of dual sourcing. This involves close collaboration with the Technical Engineering, IPT and Quality teams. Coordinates and facilitates the Material Review board Cross Functional Assessment team. Ensure that objectives are effectively achieved, consistent with Company’s requirements to ensure compliance, safety and reliable supply to the customers. Drive compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) and good documentation practices (GDP) in the performance of day to day activities and all applicable job functions. Target Right First Time (RFT), 100% of the time. Drive continuous improvement by leading and active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Manage root cause analysis of issues, using standard tools and methods, to resolve associated issues e.g. Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action through the change management system. Work collaboratively to drive a safe and compliant culture on site. May be required to perform other duties as assigned.  Minimum Qualifications and Experience:  Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline. SAP Knowledge essential. Green Belt preferable. Experience supporting quality related issues. Experience working with quality management systems. Change Control/ Change Management experience preferable. Considerable experience in a comparable role; contributing to the business at a directional, strategic level; ideally in a manufacturing, preferably GMP setting. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Understanding of business and operations management models and their application. Ability to complete investigations and excellent report writing skills. Excellent use of Excel and generation of report / standards and policy writing skills required. Lean Six Sigma Methodology experience desired. Having a strong safety ethos. Understand the specific responsibilities of all site functions as they relate to one’s own department as well as the network governance groups. Have shown the ability to effectively manage complex projects across multiple disciplines. Demonstrate analytical and systematic problem-solving skills. Strong change management skills. Effective conflict resolution & Negotiation skills. Strategy planning and development. Risk management skills  To Apply:  If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us: 14 Danville Business Park, Kilkenny, Ireland. +353 56 77 90100. recruitment@prochem.ie   Click here to submit your CV   Please note, we do not require agency assistance with this role.  .

874 days ago