Product Steward

Site Name:
Belgium-Wavre

Posted Date:
Jul

_ Product Steward - Project_:

Job purpose:

Context:
This position creation is linked with the WN-436 project. What is the WN-436 project? It is the construction of the new secondary building. This building will be dedicated to freeze-dried products and will have a capacity of 70 million vials.

What will be your future job during this project? You will be in charge to manage the transfer of Live and Non live vaccines from other Belgian production units.

If you are interested in product lifecycle, innovation and you are willing to manage a product transfer, this position is for you

Expectation:

Owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical parameters, ensuring process(es) are robust, in continued state of validation and continuously improving.

Ensures seamless flow of knowledge and information across functions, and with other Sites/MPU when applicable, with focus on the product(s) & associated process.

Provides second line technical/scientific process support.

In this role you will:

Process/product oversight and knowledge:

• Maintain the oversight of the process of the product(s) assigned 'door to door' at the Site/MPU (e.g. from raw materials to primary packaging).
• Maintain the knowledge and the history of the product(s) process throughout the entire commercial lifecycle, since transfer from development to date.
• Manage issues/risks detected through CPV, AQR/PQR, investigation, change control, data trending, etc and escalate to appropriate governance as needed

Single Point of Contact to Head of product steward:

• Liaise with Head of product steward and with functions (Quality Assurance QA, Quality Control QC, Engineering, Regulatory Chemistry Manufacturing & Controls (Site conformance), etc), production management (e.g. Process UnitHead, Production Head, etc), shopfloor (e.g. Operators, Team Leaders, etc), with focus to ensure and improve product process capability, to keep up to date the knowledge of the process and to maintain the product/process in constant state of validation.
• Create and maintain a product specific Technical Risk Assessement (TRAs).

Continued Process Verification (CPV), data trending and statistical analysis:

• Track CPV parameters from production, QC, control systems, etc. Monitor all critical variables and key

- variables as appropriate for the assigned product(s) (Critical Process Parameters CPP, In Process Control IPC parameters, Quality Attributes, Characteristics of raw materials. etc) using statistical analysis and conducting regular product specific data trending.

• Utilize data trending and statistical analysis to:
• Deepen and broaden process understanding and knowledge.
• Detect issues in process capability, such as systematic quality defects.
• Identify trends of process deviations (e.g. deviation with common root cause).
• Issue quarterly/annual data trending report.
• Ensure data and trending is visible and communicated at shopfloor level.

Transfer OUT process:

Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.

Investigations/improvement on product:

• Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving crossfunctional teams.
• Actively participate and represent their product(s) & processes in the relevant committee, where the improvements on weak point products are planned, prioritised and monitored.
• Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters.

Validation:

• Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samples.
• Supports Validation Experts to assess need and plan validations / revalidations / verifications/Annual Monitoring Batches, consulting approving and reviewing the process validation master plan, together with Validation Experts.
• Write both Validation Protocols and Report

Testing Monographoversight:

Ensure oversight on Testing Monograph, liaising with Analytical Services to ensure consistency of content.

Change control:

• Participate and/or lead (case by case) the change controls to its products and related processes.
• Ensure alignment of (regulatory) timelines for technical changes (e.g. DS), transfers or launch, major deviations.
• Evaluate impact of change control on process validation

Annual Product Review/Product Quality Review (APR/PQR):
Review the PQR data and provide the correct level of discussion on it.

**Training*

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