| || • Maintain the oversight of the process of the product(s) assigned ‘door to door’ at the Site (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.
Single Point of Contact to Global Product Steward:
• Liaise with Global Product Steward at global level and locally with functions (Quality Assurance QA, Quality Control QC, Engineering, Regulatory Chemistry Manufacturing & Controls (Reg. CMC), etc), production management (e.g. Process Support Lead, Facilitator, etc), shopfloor (e.g. Operators, Coordinator, etc), with focus to ensure and improve product process capability, to keep up to date the knowledge of process and to maintain the product in constant state of validation.
• Create and maintain a product specific Quality Risk Analysis (QRAs).
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.
• Assist initiating the product-specific monitoring of all critical In Process Controls (IPC) and release parameters in each laboratory (transfer of the product-specific Quality Risk Analysis).
• 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 cross-functional teams.
• Actively participate and represent their product(s) in the relevant committee (e.g. Product Stewardship Committee), where the improvements on weak point products are planned, priorised and monitored.
• Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical
variables and use the output to verify critical process parameters.
• Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samples.
• Supports Validation Lead and Experts to assess need and plan validations / re-validations / verifications /Annula Monitoring Batches, consulting approving and reviewing the process validation master plan, together with the Validation Lead or Validation Experts.
• Approves both Validation Protocols and Report