Overview
Provide full Manufacturing Quality support and expertise for planning, execution, research, development of innovation and improvement projects while ensuring manufacturing line readiness for production execution in a non-commercial environment. Responsible for product and process performances on the shop floor, providing technical and analytical direction to solve quality issues related to in-line control systems, visual quality, at-line instrument management, brand integrity and traceability and other manufacturing processes.
Responsibilities
* Coordinate samples testing and scheduling between Production and Laboratories to support product and relevant data analyses delivery on time.
* Manage retention samples with appropriate inventory, storage and destruction of finished product samples.
* Ensure the improvement and/or maintenance of the Quality Management System (QMS) with related procedures and instructions in alignment with QMS Compliance and Central Quality functions.
* Provide Manufacturing Quality support and expertise to improve product and process quality performances within innovation and improvement projects during all stages of development. Support project teams in identifying risks in Manufacturing, provide solutions for risk elimination and/or control while ensuring full compliance to Quality requirements. Provide inputs to Process and Area owners for adjustments and improvements to ensure timely readiness for commercial production.
* Coordinate the availability and testing of samples according to the sampling plan and the corresponding Control Strategy.
* Perform laboratory analysis requests using systems (LIMS/ARMS/GOLD/PDIMS, etc.) and compile results.
* Execute and manage VQA analysis for all stages of development.
* Coordinate and ensure instruments for quality check calibration and readiness before and during testing/prototyping activities.
* Manage the retention, storage and destruction of finished product samples; keep the corresponding retention database up to date.
* Collaborate with internal and external colleagues by applying risk-based approaches and effective information exchange to assess control systems, processes and product performances and ensure Compliance with PMI requirements, standardization and continuous improvement during development.
* Execute internal and external training to relevant PMI employees as a subject matter expert in Manufacturing Quality and Product and Process control; guarantee proper knowledge transfer to commercial teams prior to project closure.
* Execute required actions per defined project plan or support request, ensuring all actions are on schedule and within requirements. Provide timely updates to the project owner. Perform data analysis reviews in line with Company requirements. Ensure objectives and targets related to quality are defined and followed up by the project team or stakeholders. Present quality-related results in project review meetings.
* Investigate non-conformities and deviations related to product and process performance during tests and prototyping and other development stages; determine root causes, implement preventive/corrective actions, and maintain related databases.
* Based on stakeholder recommendations, participate in decisions to release or destroy non-conforming products blocked due to quality issues and monitor related costs.
* Act as SME in development and qualification of new and/or improved in/on/at-line controls by coordinating first installation plan execution including documentation, reporting and assessment. Establish Quality documents and procedures supporting good manufacturing practices for reference packaging. Ensure capability establishment in pilot site to use, maintain and control new controls in a commercial environment.
* Act as SME in establishment of Quality documents and procedures supporting good manufacturing practices and the technical transfer package. Provide general QMS training and coordinate quality-related training within the department.
* Support QMS compliance department in ensuring QMS efficacy, adherence and compliance within the Quality department.
* Carry out activities ensuring PMI Compliance Policies, Standards, and Laws are respected, integrated and understood by stakeholders, and implement processes to protect confidential information.
* Promote and apply rules concerning PMI Quality, Environment, Health and Safety. Report situations requiring actions to minimize risks to personnel, assets and societal impacts in line with applicable laws and standards.
Qualifications
* Professional School (Mechanical area), College/University degree in Physical sciences, Manufacturing/Food Engineering or equivalent competencies through technical training and demonstrated experience.
* 1-2 years experience in production, quality or relevant skills through demonstrated experience.
* French: Fluent; English: Intermediate.
* Knowledge of International standards (ISO). Advanced knowledge on manufacturing processes, quality tools, root cause analysis, analytical skills, statistical tool knowledge. Ability to transform data into information (reporting skills).
Don’t hesitate to apply.
Settore: Industria farmaceutica
Ruolo: Produzione
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