· Experience in Validation, clinical research, pharmaceutical, Life Sciences Industry with ability to withstand on IT projects.
· Excellent knowledge of full Software Development Life Cycle (SDLC).
· Through knowledge of 21 CFR Part 11, 50, 210, 211, 820 and experience working in cGMP, cGLP, and cGCP suites.
· Advanced knowledge of SharePoint, and Microsoft Office, including Word, PowerPoint, Excel and Access.
· Hands on experience with temperature mapping of various chambers including Incubators, Freezers, analytical Thermocyclers, PCRs, Inc etc.
· Used Kaye Validators for CTUs to map various units.
· Maintained the Calibration data for the Kaye Validators and Data Loggers to meet the thermal validation needs
· Ensures accuracy and completeness of software validation records like Validation Master Plan (VMP), Installation Qualification, Operational Qualification, Performance Qualification, Data Migration protocols.
· Extensive understanding of GxP Environments, GAMP guidelines and FDA Regulations.
· Specialized in user requirement analysis, developing validation plans and managing the scope of validation based on corporate validation standards.
· Involved in Computer System Validation, 21CFR Part 11 and audit trail validation process.
· Proficient in writing, reviewing and modifying Validation Plans, Standard Operating Procedures (SOPs) and Validation Summary Reports (VSRs).
· Created and executed qualification testing protocols (IQ, OQ and PQ).
· Well versed with GAP Analysis, Remediation Plans, Trace Matrices and Risk Assessments.
· Authored Deviation Reports and prepared Final Validation Report.
· Strong analytical skills, with outstanding abilities in strategic planning, problem solving, decision making, time management and communications.
· Excellent clinical laboratory skills with commended performance conducting/ analyzing laboratory assays and resolving complex clinical and instrument problems.
· Dedicated researcher offering excellence in molecular techniques including chromatography, HPLC, PCR, SDS – PAGE, RFLP, Spectrophotometry, MALDI TOF- MS, Electro blotting and Isolation and transformation of DNA, Plasmid and RNA from Bacterial and Yeast Cells.
· Ability to perform microbiological Techniques including Cell Culture Techniques, Biochemical Test Analysis and Clinical Sample Testing.
· Independently Performed Batch Fermentation on 7 L fermenter (Bioflow 115, New Brunswick), also Applikon autoclavable (7 L) and Applikon insitu (20 L).
· Extensively experienced with immunological including preparation of ELISA kits and Proteomics Techniques including protein isolation.
· Well versed with the knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).
· Work well under pressure and time constraints with high volume environments.
· Good knowledge of Ethics in Clinical research, International Conference on Harmonization Guidelines (ICH), Regulatory requirements: FDA and Drug Control, Investigational New Drug Application (IND) and New Drug Application (NDA).