Validation Lead 工艺验证经理

Major accountabilities:

Stewardship

• Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC.
• Create and maintain a product specific Quality Risk Analysis (QRAs).
• Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
• Review APQR and decide on state of control.
• Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross functionalteams.
• Ensure inspection readiness for all process related aspects of assigned products.
• Present product performance and status of product improvement projects in site Manufacturing Robustness Review Board(MRRB).
• Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
• Harmonize and optimize technical processes across the site.
• Maintaining the process control strategy.
• Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
• Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV), ongoing cleaning verification.

Qualification & Validation

• Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC.
• Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
• Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning,packaging validation and ongoing process verification (OPV), ongoing cleaning verification.
• Maintain all validation activities in an inspection ready status. Product is maintained in constant state of validation
• Author complex validation protocols.• Establish local procedures & templates for respective validation documentation.Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP.
• Handling any deviations associated to these activities including oversight of pre-validation and validation resulting fromtechnical changes.
• Provide technical expertise (and may facilitate) pre-validation risk assessments using risk management tools.
• Support Site MS&T Head in ensuring that responsible departments execute and maintain the VMP activities.
• Prepare Qualification documents of equipment with leverage to Global standard Qualification approach/practice.Engage cross functions including 3rd party to ensure that all PQ activities are performed and are in line with the currentNovartis requirements and cGMP, handling any deviations associated
• Ensure PQ activities and Documents along within project schedule and budget
• Facilitate execution of integrated line PQ, provide insight to finalize process design.
• Execute smoke study, VHP PQ and all PQ activities allocated

Key performance indicators:

• Cost, C-Sat and productivity targets 
• Achievement of project plans & milestones 
• Internal customer satisfaction with quality of services provided 
• Validation Master Plan (VMP) completed and up to date.
• Product maintained in a constant state of validation.
• Transfers/launches implemented on schedule and on targeted Quaility.
• Validation approach meets Novartis QM requirements, health authority and industry standards
• OOS, OOE, Deviation, CAPA, compliant, recall – process-related.• Completeness of Regulatory CMC dossier.
• All related SOPs are updated on time.
• Success rate of Health Authorities’ inspections.

Minimum Requirements:
Work Experience:

• Cross-functional experience
• Functional Breadth
• In-depth Technical Expertise
• Operations Management and Execution
• Working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
• Proven project management experience in a cross-functional environment
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• Willing to work in workshop for validation activities in related

Languages:

• English.
• Chinese