Validation Lead - ASPEX job in Fort Worth
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
Develops, implements, and manages site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies' requirements.|
Validation Master Plan:
• Establish and maintain the Validation Master Plan(s) (VMP) for process, product, aseptic manufacturing (media), cleaning, and packaging validation.
• Support MS&T Site Head in ensuring that responsible departments execute and maintain the VMP activities including annual revalidation process and cleaning procedures.
• Maintain overview of state of validation at site and establish the project prioritization across site.
• Partner with other functions (e.g. via division, regulatory inspection, changes in regulations) to establish and maintain common validation approach and translate that for the site.
• Partner with Engineering and IT and QA to define the process validation/equipment/systems qualification interface.
• Establish and manage the respective validation plans by aligning, coordinating and supervising the prioritization of activities against the business needs. Reviews risk assessments for validation.
• Establish and maintain Annual Monitoring Batches (AMB) that ensure all critical process parameters and quality attributes are monitored or analyzed, and actions taken in case of trends or deviations.
• Ensure Continued Process Verification (CPV) plans are in place to monitor and trend critical process parameters and critical quality attributes. Review CPV risk assessments for Validation.
• Responsible to translate the critical process parameters and the process control strategy into a focused validation plan for process validation.
• Establish Risk Assessment program and provide guidance to site process owners for performing risk assessments. Review risk assessments for Validation.
• Provide input to Quality Manuals (QM)/Quality Directives (QD)/Global Standard Operating Procedures (SOPs) and Technical Guidance Documents (TGDs) to ensure the document is in line with global/local requirements and industry standards.
• Set local procedures and templates for respective validation documentation and validation master plan.
• Ensure that all site validation activities, including pre-validation and validation resulting from technical changes, are performed and are in line with the current Novartis requirements and cGMP, handling any deviations associated with these activities.
• Author or oversee complex validation protocols (e.g. launches, transfers, weak point remediation).
• Ensure revalidation requirements are met.
• Ensure Validation oversight review and approval of Production documentation, e.g. Master Batch Records (MBRs) and Standard Operating Procedures (SOPs).
• Ensure Validation oversight review and approval of change control documentation.
• Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
• Support process qualification for new equipment and new technologies. Ensure consistency with process needs defined by Manufacturing and/or Engineering.
• Participate in improvement and remediation of products.
• Be a senior advisor in case of difficult validation challenges at site.
• Ensure a proper prioritization approach for High Level Product Assessments, product validation, compliance activities.
• Establish and monitor validation Key Performance Indicators (KPIs).
• Own the Training Curriculum for assigned Job Profile and provide training and support to new associates joining related functions.
• Maintain assigned documentation and work area in inspection readiness level and provide necessary support in any internal or external audit.Bachelor's Degree or equivalent years of directly related experience
The ability to fluently read, write, understand and communicate in English
7 Years of Relevant Experience
5 Years of Demonstrated Leadership