Sanaa Amguoune

Overview:

Driving operational readiness for $40B DKK capital expansion program across three continents, focusing on creating cutting-edge manufacturing sites using modular technology to enhance capacity for existing products and launch new offerings.

Key Responsibilities:

• Directed and mentored project managers and specialists in executing operational readiness plans, including training, SOPs, failure mode risk assessments, supplier support, and hypercare.
• Cultivated collaboration between training, ITOT, and quality assurance to ensure optimized manufacturing processes (maintain standard, business continuity plans, CAPA readiness, recovery plans).
• Aligned process design with capacity targets while supporting organizational growth through strategic manning and hiring plans.
• Defined product transfer strategies, forecasted capacity bottlenecks, and provided technical expertise and implemented solutions for critical business challenges.
• Communicated effectively with senior leadership to provide progress updates and drive performance metrics.

Overview:

Led operational readiness for a $40B DKK capital expansion program across three continents, focusing on creating cutting-edge manufacturing sites using modular technology to enhance capacity for existing products and launch new offerings.

Key Responsibilities:

• Scope Definition: Define operational readiness scope and deliverables, ensuring alignment with organizational goals and timelines.
• Team Development: Recruit and onboard project managers and specialists, equipping them for effective operational readiness execution.
• Layout Optimization: Collaborate with stakeholders to design initial layouts and optimize physical workflows for manufacturing processes.
• Simulation Tool Creation: Develop and implement a module simulation tool to enhance and streamline operational workflows.
• Global Team Coordination: Establish a global team across sites to ensure cohesive execution and best practice sharing.
• Leadership Collaboration: Work with senior leadership to set strategic direction for the ramp-up phase, ensuring successful implementation and transition

Overview:

GMP, compliance and and engineering expertise, supporting the review of case studies for conceptual design of aseptic manufacturing facilities

Overview:

Led the review and redefinition of product portfolio for new digital team supporting tablet manufacturing.

Key responsibilities:

• Developed and prioritized product portfolio and backlogs based on stakeholder feedback and market analysis to ensure alignment with strategic goals.
• Collaborated with cross-functional teams to define product vision and requirements for new features.
• Conducted user research and gathered insights to refine product offerings and enhance user experience across multiple platforms.
• Facilitated agile ceremonies such as sprint planning, daily stand-ups, and retrospectives to maintain team alignment and project momentum.

Overview:Promoted from Project Engineer to Project Manager for a DKK 2B greenfield capital expansion project of an aseptic filling facility, leading efforts from CQV through ramp-up.

Key Responsibilities:

• Validation Execution: Oversee the validation of formulation equipment in scope in alignment with established validation plans, including creating documentation, supplier audits, testing, reporting, and deviation management.
• MES and ERP Implementation: Serve as the subject matter expert and master data steward for the design and implementation of MES and ERP systems within the formulation area.
• SOP and Training Development: Create standard operating procedures (SOPs) and training materials, and manage CAPAs and audit presentations during the submission and ramp-up phases.
• Project Management of MES: Lead the implementation and updates of the MES system across all aseptic processes utilizing agile frameworks

Overview:

Shift leader of technicians team in the formulation of injectable products.

Key responsibilities:

• Led Manufacturing Operations: Directed daily manufacturing activities to ensure compliance with quality standards and production schedules.
• People leadership: Hired, managed and trained new employees on safety protocols, equipment operation, and production processes, enhancing team efficiency.
• Process Optimization: Monitored workflows and implemented process improvements to minimize downtime and facilitate smoother production transitions.
• Cross-Functional Collaboration: Worked closely with cross-functional teams to identify improvement areas, resulting in optimized operations and cost savings.
• Incident Analysis Participation: Actively participated in root cause analyses following incidents or near misses, implementing corrective actions to prevent recurrence.

Overview:

Validation Consultant – Fermentation of Hydrocortisone Production

Key Responsibilities:

• Validation Coordination: Oversee and coordinate validation testing activities for operators.
• Results Review: Review and approve validation results to ensure compliance with established standards.
• Problem-Solving Participation: Engage in problem-solving workshops to address operational challenges.
• Non-Conformity Management: Manage and resolve non-conformities to maintain quality assurance.