Sr. Specialist

 

Description:

This role will lead Quality System related activities for raw material evaluation and/or qualification relating to West supplier driven raw material changes and second source initiatives to ensure no impact to the quality of West Products.

  • Participate in Raw Material Review Board (RMRB as Quality representative to assess raw material supplier driven changes / second source initiatives to develop necessary actions/tasks and determination of change levels.
  • Engage with R&D and Procurement on project prioritization activities associated with Supplier driven changes and second source initiatives.
  • Collaborate with other West functional areas and drive optimization of raw material change management processes and procedures and bring resolution to issues
  • Collaborate with global cross functional team to review supplier change notifications and assess impact on West purchased raw material or products. risk assessments for raw material changes.
  • Provide guidance on Raw Material performance and historical data to Quality Operations, as needed.
  • Provide Raw Material/Chemical analysis and consultation as it relates to West’s rubber formulations
  • Prepare and/or review applicable documentation related to raw material change assessments. This includes but not limited to change controls, risk assessments, test methods, and laboratory data.
  • Lead raw material use by date harmonization program; Communicate with impacted cross functional teams on established raw material use by date changes.
  • Review and approve material performance evaluations documentation and data to support changes
  • Serves as the Quality point of contact on assigned projects.
  • Review and/or approve Incoming Raw Material Purchasing Specifications.
  • Lead raw material test specification periodic reviews to ensure accuracy and compliance with applicable procedures.
  • Drive solutions to internal customer raw material related problems/issues and communicate resolutions as needed.
  • Perform and assist with other Quality related responsibilities and duties as assigned
  • Support corporate harmonization initiatives as they pertain to the quality management system.
  • Prepare and Review Procedures as appropriate
  • Utilize knowledge and experience to identify initiatives to improve the effectiveness and/or efficiency of systems.
  • Execute activities relating to West Quality strategic plans and policies for assigned business unit(s), projects, products and customers.
  • Generate, review, or approve Quality related documentation.
  • Education: Bachelor’s degree in chemistry or related science preferred or equivalent experience in related discipline.

Organization West Pharmaceutical Services
Industry Medical / Healthcare
Occupational Category Sr Specialist
Job Location Waterford,Ireland
Shift Type Morning
Job Type Full Time
Gender No Preference
Career Level Experienced Professional
Experience 8 Years
Posted at 2022-11-08 10:28 am
Expires on Expired