Area: Pharmaceutical Industry, Chemical Manufacturing, Change Management, CAPEX and Operations

Lead, coordinate, manage and support projects with broad knowledge in the areas of CSV, Engineering, R&D, Manufacturing, Quality and Automation in the pharmaceutical and biotechnological environment in large and small pharmaceutical companies.• Strategic decisions, task oversight, deviation planning and ensuring timelines and transparency• Stakeholder management in a cross-functional environment• Implementation of strategies for continuous improvements• Deliver creative and efficient solutions in a fast-paced environment• Accelerated QA: Oversight of QA CSV activities in the areas of Production, Quality Control and Data Integrity• Coordinate and plan meetings, reviews and projects in the QA CSV and automation area to ensure progress of current projects (GMP readiness, plans, protocols, deviations, etc.)• Managing Implementation of new global SOPs cross-functionally (including gap analyses and restructuring of current documents) as well as planning the desired timeframes and actions

• Project Lead for implementation of CPV on R&D production site• Successfully harmonized digital solution across global production sites (coordination between Capgemini sites Morocco and Belgium with customer sites Netherlands and Switzerland) using hybrid project management (waterfall and agile approach)• QA support and oversight of qualification and validation activities (IQ, OQ and PQ) within Automation Engineering & Quality with regard to new biopharmaceutical production lines• Solving problems in cross-functional project environments with other departments (Quality Assurance, Operations, Engineering, Manufacturing, Validation)

Responsible for market release activities, implementing and managing the local QMS (point of contact), management of deviations, CAPAs, supplier qualification and oversight of quality agreements, support of external audits and self-inspections for areas in scope

Coordination and management of process validation activities in API production plants, conduct internal audits, mitigating and managing risks (FMEA) of production processes as part of the process validation for new processes in cooperation with production and research & development departments including CAPA and deviation management