Brussels, Brussels Region, Belgium
Senior Quality professional with broad manufacturing and laboratory experience in the sterile pharmaceutical and biotech industries. Extensive experience in operations, being Aseptic Operations Department Manager in Companies like Sanofi-aventis and Rovi Manufacturing, with responsibility for 50+ people. I also have strong knowledge of Quality Control, as I was leading the Quality Control Lab (Microbiology Lab & Chemistry Lab) in Abbott. During the last years in Pfizer I have been working as Aseptic Manufacturing Support Manager, applying my knowledge as SME on Annex 1, Contamination Control Strategy, Cleaning & Disinfection, APA Aseptic behaviours & Knowledge, Cleanroom Gowning, Training & Coaching, Observation program, Aseptic investigations, giving support to Site´s new Isolator facilities project and managing Site´s Excellence Plan Aseptic workstream. Successful practitioner of continuous improvement, driving best practices to achieve cost effective results while ensuring GMP compliance. Flexible, skilled leader recognized for quickly adapting to meet regulatory requirements in changing environments. High level understanding of different regulations, especially FDA, EMA, ANVISA, Health Canada, etc.
Subject Matter Expert in: - EU GMP Annex 1 and FDA Guidences - Barrier Technologies - Contamination Control Strategy - Cleaning & Disinfection - Observation Program - Cleanroom Gowning - Training & Coaching - Aseptic Investigations - APA aseptic behaviours & Techniques
Responsible for: - Develop and upskill Manufacturing Quality Assurance technicians - Provide Quality Oversight for established operations to conform with regulatoty standards - Implement process improvements to promote best practices: a) Real Time Batch record review (batch review in operations line) b) Evaluation & Reduction of Environmental Discrepancies by 70% in Site c) Refresher Training to Cleanroom sanitization Department (hands on training to 90+ people)
Production Department Manager in the Sterile Injectables area - Responsible for dispensing, manufacturing, aseptic filling, visual inspection, and final sterilization. - Manager for 70+ People and 5 production lines. - Ensure compliance with production planning , finish product quality compliance, Department Security, and Department projects developement
Quality Control Manager leading Microbiology Lab, Chemistry Lab and Material Release Department. - Manager for 25+ people between Supervisors, Technitians and Analysts. - Ensure effective performance of: 1. Department planification (Micro samples, Chemical analysis, Material tests) 2. Deviations investigation 3. Complaints re-tests 4. Retained samples 5. External and Internal audits 6. Anual Product Review 7. Analisys of Trends - Guarantee alignment with current GMP Regulation and Pharmacopeia.