QA Supplier Specialist

Customers globally rely on our extensive range of products and services—

from life-saving medicines to lab essentials to next-generation instruments.

Our Operations team leverages our PPI (Practical Process Improvement Business System) to manufacture and produce these products and continuously improve productivity and quality all while contributing to our Mission - to enable our customers to make the world healthier, cleaner and safer.

Job Summary
The supplier quality senior specialist role is charged with encouraging supplier management practices across site.

This role is the single person leading supplier quality assurance and will own/promote/define the systems listed as key responsibilities (80%).

The role is also an integral part of a matrix supplier quality organization both within the site and across the other VVS sites within the network with the purpose to harmonize the practices (20%).

Context

Production of biopharmaceutical products conform to the requirement of international quality defined by the FDA, the EMA, the ICH, etc.

The site conforms to the cGxPs rules and established by the ministers of health and the social protection of countries, as well as the international directives.

To guarantee the global competitiveness of the sites, the production activities need to be completed in an effective and efficient way, and also in a highly controlled way, due to the high value of the intermediate and finished products.

The control of the compliance of the production activities to the rules, regulation and cGxPs directives is essential for the client's products quality and the site operating license.

Principal areas of responsibilities

• Accountable for the qualification, maintenance and performance followup of services and raw materials suppliers in compliance with applicable cGxPs standards Promote understanding of and compliance to supplier quality related regulations such as EU & the FDA's standards.
• Responsible for supplier change notifications management Support the site in all investigation linked to supplier issues
• Responsible for the creation, modification and maintenance of supplier data within SAP Manage supplier qualification files :compliance and maintenance
• Responsible for supplier quality agreement included important metric and action plan follow up
• Support the site and the projects to assess the criticality of a supplier of services and raw material
• Quality oversight for all activities linked to services and raw materials
• Ensure internal audit and gemba of site activities related to services and raw materials ie warehouses, transfer, storage conditions, validation, elimination
• Contact suppliers or internal services to plan supplier audit in accordance with applicable standards or project needs.
• In charge of the communication of the audit plan with suppliers and internal services according to applicable procedure/quality agreement.
• Responsible to write and communicate supplier audit report according to applicable procedure/quality agreement
• Responsible for the follow up of all CAPAs issued from supplier audit report Responsible to assess change notification from the suppliers and to define action plan if applicable assess if change control required.
• Support supplier deviation investigation
• Maintain and continuously improve the supplier management process (performance, tools and knowledge)
• Act as the site SME within the TF quality supplier community
• Owner of the supplier quality procedures for the site act as trainer for the topic
• Define, coordinate and, where applicable, improve the supplier quality programs. Leverage and support the supplier identification based on the TF supplier data base.
• Conduct gap assessments and improvement programs to ensure that supplier quality practices stay aligned with current and future regulatory expectations. Call out any supplier quality issue to the management and the network if applicable
• Act as quality supplier SME with regulators/clients (i.e. key part of major audits) Act as supplier quality SME for new product introduction Report status of and promote supplier quality within the Senior Leadership Team

In addition:

Represents the site/business unit within the supplier quality working group; actively harmonizing practices across sites in the network.

Leadership skills (potential future development opportunity for all quality supplier SME)

Support QA Operations activities for the end of the Maestro Project

Eh&s:

Support and promote EH&S impact assessment of services and raw material used on site

Understand and ensure implementation of emergency procedures and safe systems of work Ensure compliance with environment, health, and safety rules, signage, and instructions at all times Ensure prompt reporting and investigation of all accidents, near misses, and breaches of rules.

Contact with the authorities:
Support and active participation to the audits and inspections

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