Supt, Quality Compliance - Tijuana, México - BAXTER

BAXTER

Empresa verificada

Tijuana, México

hace 3 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

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.

Oversees compliance with regulatory requirements of countries to which the product is exported, applicable international standards and adequate alignment of corporate requirements.

Prepares quality records, such as:

regulatory letters, product characteristics of locally manufactured medical device, required for submission to regulatory entities, necessary for audits or product registration.

Develops and coordinates the Annual Internal Audit Schedule, ensuring the correct: Planning, Execution, Root Cause Assessment and CAPAs, through the TW9 and TW8 tool.
Analyze responses to audit reports and effectiveness of preventive actions.
Support the training program through training and qualification of Auditors and promotes understanding of regulatory standards such as: ISO 13485, CFR 21-Part 820, 201,211, 11 and other applicable GxP regulations.
Coordination of preparation activities (Reediness Plan) and follow up for interactions with regulatory agencies, External Audits, Inspections and Global Internal Audits, maintain effective communication with auditing entities (BSI, TUV and applicable MOH).
Performs compliance analysis and develops action plans for non-compliance risks detected during internal assessments, keeps management team aware of any non-compliance risks.
Responsible for the administration of the Global Observations Program [GOCs].
Responsible for the development and follow-up of the Quality Plan for the subsidiary, derived from the evaluation of regulatory compliance, GOCs, and benchmarking.10.Analyzes trends and identifies areas of continuous improvement related to regulatory compliance, simplification and savings, manages and develops projects with this focus.11.Responsible for establishing a GEMBAS program to identify opportunities for improvement and promote understanding of GxP.
Supports Quality System compliance through participation in investigations ensuring that activities related to NCR/CAPA follow-up are properly executed, completed and documented. In addition, if involved as a quality approver, has the responsibility to ensure that investigations have had an adequate root cause investigation and that investigation closures or actions have been properly executed, meet system requirements and are properly documented.
Foster a culture of compliance with ethical standards and practices in the organization.
Support programs and initiatives related to the Code of Conduct, Cultural Levers and continuous improvement programs.

Reasonable Accommodations

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