Job Summary
This role focuses on delivering comprehensive quality support and expertise for project planning, execution, research, and development. It ensures manufacturing line readiness for production execution in a controlled environment.
Key Responsibilities:
* Provide technical direction to resolve quality issues related to In-line Control systems, Visual quality, at-line instrument management, Brand integrity, traceability, and other Manufacturing processes.
* Coordinate sample testing and schedules between Production and Laboratories to deliver product and relevant data analyses on time.
* Manage retention samples while maintaining appropriate inventory, storage, and destruction of finished product samples.
* Maintain the Quality Management System (QMS) with related procedures and instructions aligned with QMS Compliance and Central Quality functions.
Additional Tasks:
* Support innovation and improvement projects throughout all stages of development by providing quality expertise.
* Identify risks in the Manufacturing area and provide solutions for risk elimination and/or control, ensuring full compliance to quality requirements.
* Collaborate with Process and Area owners to adjust and improve corresponding systems and/or processes, ensuring timely readiness for commercial production.
* Ensure the availability and testing of samples according to the sampling plan and Control Strategy.
* Perform laboratory analysis requests using different systems and compile results.
* Execute VQA Analysis for all stages of development.
* Coordinate instruments calibration and readiness before and during testing/prototyping activities.
* Manage retention, storage, and destruction of finished product samples, keeping the retention database up-to-date.
* Collaborate with internal and external colleagues to assess control systems, processes, and product performances, ensuring compliance with PMI requirements, standardization, and continuous improvement.
* Share expertise and drive excellence within PMI through training sessions as a subject matter expert in Manufacturing Quality and Product/Process control.
* Guarantee knowledge transfer to commercial teams prior project closure.
* Investigate non-conformities and deviations related to product and process performance during tests and prototyping, and other innovative or improvement projects stages.
* Direct decision-making for quarantine non-conforming material/products.
* Liaise with concerned parties to identify root causes and take preventive/corrective actions.
* Monitor open actions and maintain the related database up-to-date.
* Establish Quality documents and procedures supporting good manufacturing practices to be included in reference packages.
* Educate on quality management system training and coordinate quality-related training within the department.
* Sustain QMS efficacy, adherence, and compliance within the Quality department.