Quality Assurance Specialist

2 mesi fa

Roma, Lazio, Italia Baxter A tempo pieno

About Baxter

Baxter is a leading global healthcare company that pioneers medical innovations to transform healthcare. Our mission is to save and sustain lives, and we're committed to making a positive impact on people around the world.

Job Summary

We're seeking a Quality Assurance Specialist to join our team. As a key member of our Supplier Quality team, you'll be responsible for managing Supplier Quality Assurance and Maintenance activities for assigned suppliers.

Key Responsibilities

  • Independently manage Supplier Quality Assurance and Maintenance activities for assigned suppliers.
  • Execute quality assessments/audits, negotiate and implement Quality Agreements, and monitor and report metrics.
  • Manage Quality and Compliance related issues between suppliers and Baxter.
  • Set Quality system requirements to suppliers within the employee's defined commodity portfolio.
  • Perform Qualification of suppliers to medical device, pharmaceutical, combination devices, and/or biologics standards and oversee their placement on the Approved Supplier List (ASL).
  • Conduct and oversee supplier audits-qualification and re-qualification, including finding closure.
  • Oversee and negotiate Quality Agreements between suppliers and Baxter.
  • Assess and process changes induced by the supplier and/or Baxter.
  • 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.
  • Manage and oversee Purchasing controls CAPA, including root cause identification, and effective and timely closure.
  • Develop and/or deliver training to internal teams and suppliers, administer training systems.
  • Execute SCAR management, effective and timely closure, and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed.
  • Accountable for NCR (non-conformance reports) as assigned, conducting NCR timeliness and effectiveness reviews, and trending for actions.
  • Support Manufacturing, Regulatory, Quality, and Purchasing organization for third-party suppliers related activities, as applicable.

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; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her industry, business, and organization.
  • 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.

Education and Experience

English, Master's Degree (±18 years)

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