Quality Assurance Specialist

1 giorno fa

Roma, Lazio, Italia Baxter A tempo pieno

About Baxter

Baxter is a leading global healthcare company that saves and sustains lives. Our mission is to improve healthcare outcomes for millions of patients worldwide.

We are committed to innovation, quality, and customer satisfaction. Our products and therapies are found in almost every hospital worldwide, in clinics, and in the home.

Job Summary

We are seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for managing Supplier Quality Assurance and Maintenance activities for assigned suppliers.

Key Responsibilities

  • Execute quality assessments/audits and negotiate Quality Agreements with suppliers.
  • Monitor and report on supplier quality metrics.
  • Manage quality and compliance-related issues between suppliers and Baxter.
  • Set quality system requirements for suppliers and oversee their placement on the Approved Supplier List (ASL).
  • Conduct and oversee supplier audits-qualification and re-qualification.
  • Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures.
  • Collect, trend, and report supplier quality metrics.
  • Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes.

Requirements

  • Knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, ISO 9001, FDA cGMP, MDD, Eudralex, other global or regional equivalent.
  • Working knowledge of US and International cGMP as it applies to the defined commodity portfolio.
  • Experience in Product/process development and/or supplier quality improvement.
  • Auditing skillsets, up to and including certified SQ lead auditor training.
  • Quality Management System auditing, and where possible, special process auditing skills.
  • Knowledge of Business Acumen.
  • Collaboration and Teamwork: Good communications, facilitation, coordination, and team skills.
  • Project management skills managing multiple issues of moderate to high complexity relatively independently.
  • Ability to manage the Quality relationship with assigned key suppliers.
  • Competence in supporting on-site/off-site supplier quality development including of resources.
  • Multi-tasking skills in a demanding fast-paced environment.
  • Superior time-management skills.
  • Superior written and oral communications skill sets.
  • Willingness and ability to travel.

What You'll Bring

We are looking for a highly skilled and experienced Quality Assurance Specialist who can join our team and contribute to our mission. If you have a strong background in quality assurance, supplier quality management, and compliance, we encourage you to apply.

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