Bussum, North Holland, Netherlands
Professional Quality Control Manager with more than 30 years experience in the pharmaceutical industry and 20 years experience in staff management. Driven by continuous improvement using LEAN Lab principles, efficient, result oriented with an eye for the health and well-being of employees. Apply all experiences in different aspects of the pharmaceutical industry to solve all kinds of company challenges and ultimately provide patients with excellent products which will improve the quality of their lives.
Activity -Lead a staff of 26 technical personnel in development, validation, performing and reporting of analytical and biochemical release testing of finished products, intermediate products and stability samples according CFR, EudraLex, ICH and WHO Current Good Manufacturing Practice for Finished Pharmaceuticals. -Quality Control Expert during GMP Supplier Audits Responsible for -All validated analytical and biochemistry assays performs according US Pharmacopeia and/or European Pharmacopeia -On time reporting of analytical and biochemical release testing -Innovation, validation and efficient use of analytical equipment and assays. -Continuous Enchantment of Quality Performance of assays, equipment and personnel. -Maintain proper documentation and records according Good Documentation Practices Projects - Reduce lead-times for all analytical and biochemistry assays. -Coordinated and supervised multidisciplinary project team to relocate all QC laboratories and successfully prepared FDA submission -Introduce working stations in QC analytical and biochemical laboratory according LEAN principles. -Reorganization of multidisciplinary tasks within the QC-department.
Supervision of QC-group for internal testing -QC team leader (4 FTE) Product Specific Assays -Planning resources QC -Coordination between Production and QC activities -QC representative in project management teams, Technical and Assay Transfer teams -QC Subject Matter Expert for HVAC and Water Systems
-Daily supervision of Group Pharmacy (4 FTE) -Coordination activities of group Pharmacy -Communication and coordination of activities for extern customers -Implementation of new equipment (CCKL, GMP-z) -Analytical advising of hospital pharmacist -Method development, validation (ICH) and implementation of pharmaceutical (HPLC, GC, IR and UV) and bio analysis of medicines.