Experience

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  Novartis

  Jan 2011 - Jan 2022

  In this capacity, I coordinate the planning and prioritisation of team activities to attain individual and corporate goals. I esure each member operate at optimal performance level through implementing process improvement and conducting investigation. I purchase chemical and chromatographic materials and consumables within competitive pricing. I maintain an appropriate stock level in line with needs of the laboratories by means of external provider. I ensure smooth execution of warehouse operations by establishing security procedures and protocols in collaboration with HSE department. I facilitate employees in resolving technical problems related to SAP WM/MM management module software. Related Skills: Stock Level Maintenance, Corrective Action Implementation, Operational Excellence, Effective Communication Following are the highlights of the value I achieved at Novartis Pharmanalytica SA: ☛ Optimised performance of internal and external warehouse staff through executing training and implementing corrective action. ☛ Drove operational excellence through improving current processes in coordination with external service provider. Weniger anzeigen In this capacity, I perform detailed QA investigation and determined analytical deviation with the training module. I transfer the stability testing of the products passed under property of Novartis to Pharmanalityca through successful collaboration with GSK. Introduce Chromeleon 7.2 CDS for LC-MS screening and quantitation of Nitrosamines in several kind of Drug Substances and Drug Products. I coordinate the management of laboratory balance digitalisation project called LabX to gain accurate research results. I liaise with team member in overseeing all aspects of Nitrosamine Project, including development and evaluation of analytical procedures by LC-MS / MS. Related Skills: Stability Testing, Analytical Procedures Implementation, Cross-functional Collaboration Following are the highlights of the value I brought to Novartis Pharmanalytica SA: ☛ Played an integral role in conducting stability studies within Novartis Targu Mures (Romania) and Novartis Strykow (Polonia). ☛ Enahnced personal knowledge regarding SAP warehouse management Tool, while supporting team members in handling reference standards and reagents / consumables. Weniger anzeigen In this capacity, I developed and implemented effective test procedures for ensuring top-quality of finished products. Managed all facets of assigned transfer project from conception to successful completion. I initiated a wide range of analytical techniques, including HPLC, UV, Dissolution Rate by HPLC/UV, Karl Fisher, Appearance, Densimeter, Viscosimeter, TLC, Andersen Cascade Impactor for Inhalation Products, Next Generation Impactor for Ihalation Produts to determine chemical and physical properties of a substance. Related Skills: Test Procedures Implementation, Method Validation Evaluation, Productivity Gains Improvement Following are the highlights of the value I achieved at Elcom Systems Funding Solutions: ☛ Evaluated method validation and transfer protocols and reports to produce reliable results. ☛ Reviewed analytical GMP documentation to ensure accuracy and quality of the information presented. ☛ Conducted analysis of Chromeleon to ensure top quality and drive significant productivity gains. Weniger anzeigen

  • Novartis Facility Manager and Site SAP Super User

    Jan 2021 - Jan 2022

  • Method Development Specialist at Novartis

    Apr 2016 - Jan 2020

  • Junior Method Development Specialist

    Apr 2012 - Apr 2016

  • Master Thesis

    Jan 2011 - Apr 2012
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  Micro-sphere sa

  Jan 2022 - now

  Quality assurance officer

  Quality Officer in Production and Quality Control Area: Ensure batch records are prepared for production per production schedule Review all batch documentation for accuracy and completeness Adhere to site policies and cGMP requirements while reviewing batch documentation Ensure work instructions and SOPs are followed Effectively resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release Address deficiencies and ensures timely completion of all follow-up actions for resolution to all batch review issues according to cGMP Assist in resolving quality problems/concerns related to batch review Build quality into all aspect of the product manufacturing and release process by maintaining compliance to all quality requirements Assist in Regulatory and Internal Audits / Inspections Actively collaborate as QA member during GMP training sessions for production Personnel Collaborate in the definition, management, and implementation of CAPAs Actively collaborate for continuous improvement making proposals to improve inefficient processes Weniger anzeigen