Sr Specialist Supplier Quality

6 mesi fa

Rome, Italia Baxter A tempo pieno

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary:

Independently manages Supplier Quality Assurance and Maintenance activities for assigned suppliers. Responsible for activities such as execution of quality assessments/audits, negotiation and implementation of Quality Agreements, monitor and reporting of metrics. Manage Quality and Compliance related issues between suppliers and Baxter.

WHAT YOU'LL BE DOING:

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), including ensuring the creation and maintenance of supporting evidence (Supplier Master File). 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 foractions. Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.

WHAT YOUL'' BRING:

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 English, Master's Degree (±18 years)

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