Description
PROFILE * Competent & diligent professional with an experience of 8.8 years in Clinical pharmacology and pharmacokinetic department as a Senior Research Scientist with Ranbaxy Research Lab. & 8 months with National Accreditation Board for Testing and Calibration Laboratories (NABL, govt. undertaking) spearheading as Accreditation Officer. * Experience in Quality Control/Quality Assurance unit having knowledge of the procedures based on the GLP and international standards called ISO/IEC 17025, which are used for evaluating laboratories throughout the world. * Experience in creating Standard operating procedure (SOPS) as per regulatory requirement with regard to 21 CFR for the laboratory, providing training to lab personnel, preparing schedule for Maintenance & Calibration, giving technical support to vendors and coordinating with IT department in validation and implementation of Solution for Part 11 requirements towards electronic filings. * Ensure technical up gradation for proper operation of equipments as per GLP. Ensure the implementation of CAPA and closure of the observations from internal as well as regulatory audits. * Well-versed with in Bio-analytical & Clinical Instrument Validation, Facility Qualification, and Equipment/System Qualification. * Well informed with US - -FDA, French, EU, WHO, Brazil -ENVISA, MHRA, ISO 17025:2007 & other regulatory norms to maintain validated instrumentation to conduct BA/BE studies towards regulatory filings. * Coordinator during US-FDA, EU, WHO, Brazil -ENVISA, French Regulatory & NABL-instrumentation inspections at Ranbaxy's Bio-Analytical & Clinical Lab facility. * Quality assurance and testing practices with knowledge of NuGenesis Scientific Database Management Software. * Experience in instrumentation management which involves identifying need of instruments & process to be automated in lab in order to have effective throughput, identification of vendors, procurement, site preparation, commissioning and qualification as per regulatory norms. * Experience in documentation for all aspects of GLP, Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) * Knowledge of 21 CFR Part 11. * Self motivated, hard working and goal-oriented professional with a high degree of flexibility, creativity and optimism, and, proven aptitude for quick creative and technical thinking. CORE PROFESSIONAL COMPETENCIES * To perform timely facility audits of CROs used by the department to conduct bio-equivalence studies * To carry out / Coordinate/review HPLC, MS & Weighing Balances Calibration as per SOP. Ensure that calibration meets SOP compliance and is available for scheduled operation. * To co-ordinate Installation and Operation Qualification of various equipments used for Chromatography, Sample Processing and Storage for bio-analytical operational use to support laboratory up gradation and expansion. Ensure that Equipment's Qualify and validate as per SOP and meets vendor's qualification documents * To provide operational training to users on equipments operation and minor maintenance. * Prepare and revise equipment's SOPs. Ensure technical up gradation for proper operation of equipments as per GLP. * To Control and Manage equipment's inventory used for bio-analytical operation and assist in procurement as per user requirement. Ensure control on identification usage and cost on equipments and its consumables. Supervise and Interact with internal customers and external vendors. * To evaluate laboratories as per the international standard guideline, ISO/IEC 17025. Instrumentation Software Handled * Analyst Software * Class VP Software * LC Solutions Software * Mass lynx software * Total Chrom Software * Agilent Software * NuGenesis 7.1 Scientific Database Management System (SDMS) * Archival Management System Software (ARMS)
Accomplishments
Highlights:
Keywords
