Omar Ahsan Email & Phone Number

Basel, Baselstadt, Ch

Job Description • At Novartis Radioligand Therapy performs chemical and microbiology quality control testing of following GxP principles.• Ensures the timely collection, monitoring, and reporting of Quality Key PerformanceIndicators KPIs.• Assists in Health Authority inspections and internal audits by supplying information anddocumentation in a timely manner.• Support and track the implementation and maintenance of the local Quality system in inaccordance with the Novartis Quality Manual• Manages processes and systems for all Good Regulatory Practice (GxP) QualityAssurance e.g., Change control, Training Management, Escalation Management, RiskManagement. Ensures that processes are conducted in full compliance with the GxP andthe Novartis Quality.• Contributes to an improvement of current processes and/or to an implementation ofmodified processes.• Ensures adequate tracking and on time completion of corrective and preventive actions(CAPA), including escalation of issues related to the closure of CAPA, as appropriate.• Reviews quality deliverables to ensure compliance, with health authority requirements andSOPs, including procedural documents, records, third party work, contractors, clinical trialmaterial, components, and gap assessments.• Prepares and review GxP documentation; assists in the release of GxP documentation,filing and archiving of GxP documentation Supports Compliance review of projects andinspection readiness and management.Techniques and Expertise:Raw and finished products sampling, handling, and testing. HPLC and UPLC utilizing Chromeleon.ESOPS for document management, SOPs, test methods and training. 1QEM for deviation investigation, root cause analysis and CAPA documentation.GLIMS laboratory information management system for documentation and certificate of analysis generation.GinaX for half-life and iTLC.MS Word and Excel for data analysis and experiment results. MS Teams and OneNote for coordination and tracking.

Lexington, Ky, Us

Description: Perform Quality Control laboratory functions at CDMO pharmaceutical company under ICH Q7 in compliance with cGXP. Conduct testing on raw materials, starting materials, intermediates, and final products following FDA, USP ICH, EP and JP standards. Test reference standards and stability samples.Provide necessary training and guidance to newer employees on GMP issues and analytical issues and serve as SME and QC contact for production and QA for projects.Support the maintenance and calibration of laboratory analytical instrumentation.Peer review work of other analysts and perform retests as second analyst.Document sample preparation, equipment set-up, and test results in laboratory notebooks and test record forms following GDP. Investigate OOS, OOT well as deviations from validated methods and SOP.Collaborate in revision of test methods and SOPs as required.Review contract testing are performed per client agreements.Techniques and Expertise:API and HPAPI sampling, handling, and testing. Chromatographic techniques including HPLC, UPLC, LC-MS GC, HS-GC utilizing OpenLab CDS. Analytically verified cleaning of multiuse equipment using HPLC, GC and TOC analysis. FTIR using OMNIC software. Coulometric and volumetric KF titration using Metrohm tiamo software.General wet chemistry, titration, and testing per ACS and USP methods. MasterControl for document management, SOPs, test methods and training. TrackWise for deviation investigation, root cause analysis and CAPA documentation.MS Word and Excel for data analysis and experiment results. MS Teams, OneNote and SmartSheets for coordination and tracking.

Kingsport, Tennessee, Us

Description:Conducted testing at ISO and RC14001 certified chemistry lab using cGMP and quality assurance standards.Coordinated material release and provided feedback to operations with understanding of the link between quality and process. Aided with root cause investigations and CAPA, results interpretation as well as taking necessary actions when OOS and OOT results occured.Participated in development and deployment of new testing apparatus and processes as well generated documents for SOP.Coordinated equipment repair and calibration with internal and/or external service providers. Orderd and supported department supply and service agreements.Techniques and Expertise: Following GLP and GDP practices; performed Gas Chromatography, general wet chemistry including titration, viscosity, specific gravity, density, ash, boiling point, reactivity, %sulfur, auto-titration %phosphorous and other ASTM based chemical and physical tests on raw materials, in-process and final products including P2S5, detergents, fuel and tire additives product.Used Thermo Scientific SampleManager LIMS, SAP, MS Excel.

Kingsport, Tennessee, Us

Description:Conducted testing of raw, in-process and final product testing at ISO 9001 and GMP certified polyvinyl butyral resin manufacturing plant with responsibilities as above. Used data to prepare graphs and SPC charts and interpret and communicated results and coordinated material release.Aided with root cause investigations and CAPA, results interpretation as well as taking necessary actions when OOS and OOT results were detected.Participated in development and deployment of new testing apparatus and processes and generated documents for SOP.Coordinated equipment repair and calibration with internal and/or external service providers. Supported department supply and service agreements.Techniques and Expertise: Performed chemical and physical analysis at a Resin manufacturing plant. Resin Product analysis using UV/Visual and IR spectroscopy, acid and volumetric KF titration. Following GLP and GDP practices, performed Gas Chromatography, general wet chemistry including titration, viscosity, specific gravityChemical analysis of wastewater including COD, phosphates, nitrates, ammonia, volatiles including EtOH and EtOAc, and acidity. Used LabWare LIMS, Aspen Process Explorer, PI Process Book, MS Word, and MS Excel.

St. Louis, Mo, Us

Responsible for continuing education and training of security officers in current and emerging security related issues. Training new hires in Command Center role. Duties in addition of Command Center responsibilities detailed below.

St. Louis, Mo, Us

Assign and monitor overall access control in R&D facility with different access levels related to Employees, Contractors and Visitors.Responsible for surveillance of CCTV, Noxious gas and fire detection systems.Act independently in responding to safety and security related events including fire alarms, inclement weather and hazardous material emergencies.

Filled prescriptions for retail and institutional patients.

Detroit, Mi, Us

At Department of Biochemistry. Worked on multiple lines of inquiry by setting up and performing experiments, analyzing data from experiments in order to explore and establish novel physiological properties of fungal strains.

Managed setup and operation of 12-seat call center running outbound campaigns in North America. Skills:Administrative and clerical responsibilities along with limited human resource functions.

Medical reports and professional correspondence for doctors from US and UK based clinics and diagnostic imaging centers. Skills:Typing, MS Word proficiency, familiarity with medical terminology deciphered through a variety of accents to generate medical reports, medical records and correspondence.

Karachi, Sindh, Pk

Started work on BASR (UoK) approved project on medicinal screening.- Title; "Discovery of natural and synthetic modulators of angiogenesis". - Technical Writing Proficiency. (Synopsis and reports available on request)- Enrolled in the MPhil/PhD program at University of Karachi. - Completed requisite course work for the program.- Work abandoned due to lack of resources.Lab Techniques: In depth coverage of laboratory techniques related to biochemistry and organic chemistry research. - HPLC, GC, Electrophoresis, Blotting, Centrifugation- Bacterial Culturing, PCR, Enzyme Inhibition, ELISA- NMR, X-Ray Crystallography and spectroscopic techniques - Mass, UV,Visual, IR & CD spectroscopy.

Karachi, Sindh, Pk

Learned organizational setup and applied patient specific diet plans and disease related diet considerations. Made ward rounds, performed routine paper work, records-keeping. Submitted internship on the report on the role of diet on health.

M.Sc. Final, Biochemistry

B.Sc. Honors, Science

Intermediate, Pre-Med

Matric, Science