Rudi Hollander

Current responsibilities include: - Applications support and method development for LC, LCMS and CLAM. - Installation and service of a variety of instruments (LC, LCMS, PPSQ, CLAM, GC, GCMS, FTIR, UV-Vis)

Key Responsibilities Responsibilities as for QC Analyst plus Project co-ordination within the team ensuring timely and reliable results Liaising with different laboratory groups to ensure reporting of results to all relevant departments Ensuring documentation is checked, corrected and completed for all results Assisting with allocation of projects to staff and scheduling work to meet deadlines Calibration of instruments to specifications including dissolution baths to USP physical and chemical calibration standards Mediated work related concerns between staff and management Training of new staff in the QC Team Key Achievements Reducing time taken between generating results and writing of report by reducing amount of paperwork needed Reduced paper wasted in archiving results by more efficient printing of reports Passing FDA, TGA and Brazilian audits all within 3 months

Key Responsibilities Performed analysis on development and finished products and raw materials using Assay and Related Substance testing using HPLC (Empower software on Alliance, Agilent and Waters Isocratic Systems) Dissolution (USP I and II) on finished product, development and essential similarity samples using manual and automated sampling. FTIR for identification UV-Vis spectrophotometer Wet chemistry Physical testing (hardness, thickness, friability, bulk/tapped density, LOD, disintegration, moisture by Karl Fischer) Standardisation of secondary standards Process qualification testing Analysis of cytotoxic/high containment products and raw materials Calibration of instruments Method development assistance Key Achievements Learning Empower software for HPLC within a week to be able to work unaided

Performed quality control and stability testing for various multi-national pharmaceutical companies Analysis of samples and raw materials in a production environment Assisted with documentation control including: Issue of certificates of analysis Writing and updating of standard operating procedures Writing and updating of instrument operating procedures Performing F2 calculations for bio-equivalence studies Performing analysis of products according to manufacturer methods and specifications using: HPLC (manual and automated) UV-Vis Spectrophotometer Dissolution (USP I and II) FTIR Wet Chemistry Physical Testing Standardisation of secondary standards and control of all all reference standards Calibration of all laboratory equipment Raw material testing Method development and validation Stock control of solvents and chemicals Key Achievements Designed and implemented a database for reference standard stock control and expiry notification