EngiFlex

proces validation lead CSV

Posted: 6 minutes ago

Job Description

Were are searching a proces validation lead with CSV experience to support business in the upcoming IT project, transforming the IT landscape for the MS&T department of a pharmaceutical company in Puurs.Tasks: Assist in impact analysis and detailed design for processes supported by future IT landscape Assist in creating URS(s) for project Assist SMEs in key user testing Leading validation on future IT landscape, resulting in all required validation deliverables Assist in training of end users Support hypercareSkills: Proven expertise (minimum 7 years) in CSV within pharma industry Experience with rpg code based IT apps is a plusOther: Available asap Project go live planned for Dec/2026Role Purpose:To supervise that the manufacturing program is achieved on time, every time, safely and efficiently to full satisfaction of our customers within the framework of regulatory compliance and operating within high standards of GMP, HSE, environmental protection, and good working practices in the changing IT landscape.Major Accountabilities:: Ensure quality products and processes on time, every time, safely and efficiently in his/ her responsibility area: Ensure coordination of production equipment to work properly with planned capacity in his / her responsibility area: Ensure compliance to all relevant GxP, safety standards, quality, and HSE requirements are met: Continuously drive process improvement to create value for the customer and support local and global projects: Manage/coordinate the team to work efficiently and in line with production plan and Ensure all direct reports work with right quality and safety mindset, define and Ensure training and development plans for direct reports, share knowledge and develop expertise of others: Execute continuous improvement initiatives which sustain Novartis competitive advantage: Evaluate and escalate all matters about quality, safety, people, and processes to department managers and other related associates: Support building organizational culture in line with Novartis values and behaviorsKey Performance Indicators:: Manufacturing KPI: Output, yield, cycle time: Compliance with cGMP, HSE Audits, etc.: Implement process improvement in manufacturingEducation & Qualifications:Experience:: People Challenges: Operations Management and Execution: Collaborating across boundaries: Major ChangeCompetencies:: Organizational SavvySkills & Knowledge:: Change management: Managing performance improvement: Managing business continuity: Managing budgets: Lean ManagementLanguage:EnglishDutch is a plus

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