Aseptic Processing/Product Lifecycle Steward - Pharma, Med. Device job in Fort Worth
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
Aseptic Processing and Product Lifecycle Steward for Pharmaceutical and Medical Device|
Owns the process knowledge of the products assigned throughout the commercial lifecycle, maintains oversight on process capability, through data trending and statistical analysis of critical parameters, ensures processes are robust, in continued state of validation and continuously improving and in compliance with cGMPs, SOPs, and applicable guidelines and normatives. Ensures seamless flow of knowledge and information across functions, and with other sites when applicable, with focus on the products. Provides second line technical/scientific process support.
Process/Product Oversight and Knowledge:
• 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, from inception to date.
• Primary contact with R&D as the plant Sustaining Scientist.
• Liaise with Global Product Steward and with other functions (Quality Assurance (QA), Quality Control (QC), Engineering, Regulatory, Chemistry Manufacturing and Controls (CMC), Validation, Production, Process Support Lead, Analytical Science & Technology (AS&T) etc.) with focus to ensure and improve process capability, to keep up-to-date the knowledge of the product and to maintain the product in constant state of validation.
• Create and maintain specific Product Steward dossiers.
• Primary back-up to Process Support Lead.
Investigations/Improvement on Product:
• Initiate and support investigations and improvement projects involving cross-functional teams based on data analysis.
• Actively participate and represent assigned products to the relevant governance where improvements on weak point products are planned, prioritized and monitored.
• Ensure alignment of validation documentation with stability expert and QC labs for the stability program.
• Review validations, annual monitoring batches (AMB), and Validation Master Plans (VMP), together with the Validation Lead or validation experts, for alignment and compliance.
• Provide oversight and support of the Continued Process Verification (CPV) program.
• Participate and/or lead (case by case) the change control of assigned products and related processes.
• Review the PQR data and provide the correct level of discussion on it.
• 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.
Key Performance Indicators:
• Product is maintained in constant state of validation.
• Product history is documented, available, and current from inception to date.
• Recurring deviations.
• Continuously improving CpK/PpK - process capability.
• Degree of standardization or product process.
• OOS, OOE - Out of Specification, Out of Expectation.
• Customer Complaints.
• Success rate of health authorities' inspections.
• Completeness of Regulatory CMC dossier.
• Effective CAPA - Corrective and Preventive Action
• Continuously improving yield.
• Technical reports executed on time and with the right expectationsBSc in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
Preferred: MSc, or equivalent experience.
Fluent in English
5 years directly related experience in process support role on the shop floor of pharmaceutical manufacturing and/or QA/QC.
Preferred: 15 years experience
Proven process understanding (Pharma, GMP, Regulatory aspects).
Sound experience of data handling and applied statistics is a must.