EXPERIENCE SUMMARY: * 6+ years of technical writing experience in various areas of life sciences industry like Pre-Clinical, Clinical, Chemistry Manufacturing & Controls (CMC) and Regulatory. * Extensive experience as a technical writer in a vaccines research & development and manufacturing bio-pharmaceutical industry. * Experience as Document control specialist with a company manufacturing * medical diagnostics, Sera Care Life Sciences. * Experiences in using Document control software EtQ (ERP reliance software) with basic and intermediate level training. * Experience in QMs including LMS, Change management, using EtQ. * Experience as a technical writer with the major experience on communicating with subject matter experts (SMEs) for writing, editing, revising SOPs and distributing finalized drafts of SOPs. * Experience in creating change control forms, preparing questionnaires and training documents for working professionals with presentations. * Writing and editing documents, preparing manuscripts, preparing minutes of meeting reports, questionnaires for SOP training. * Have experience in Quality Control Analysis of biotherapeutic products and obtained quality knowledge to help with effective documentation. * Analysis of raw material, active and inactive ingredients, various stages of In-Process samples, Final bulk and Finished product. * In verse with regulatory requirements for developing labels and package leaflets for different products. * Inspection, review of TMFs and experienced with data analysis, technology transfer procedures. * Experienced in Quality Management System and Regulatory requirements (FDA, GCP, GDP, GMP, GXP, ICH, 21 CFR) and documentation. (SOP, STP, Batch Records, Validation Protocols & Reports, Annual Reports, Dossiers, Quality Manuals, User Manuals etc., ) * Implemented good documentation practices (cGDP) by creating, revising, editing and distributing of SOPs as a team lead in Technical Communication Dept., by coordinating with the heads of various departments (SMEs) on time. * Successfully created and implemented solutions for easy location and retrieval of documents as per cGDP. * Working experience in project management by providing technical support relating to documentation control and project coordination. * Experienced and faced US FDA, UK MHRA, Brazil and several other Regulatory Audits. Experienced with creating Business Requirement Documents, User Case Diagrams, Process Flow Diagrams as required in various academic projects. Technical Writer, April 2012 - October 2015 Bharat Biotech International Limited. Responsibilities: * Trained in compilation and preparation of CTD, ACTD, and STD dossier's format for various countries like African, Asian countries as per their guidelines. * Creation and review of documents like, STPs, SOPs, Product Specifications, Certificate of Analysis (CoA) and Annual/Periodic Reports and of various Technical Documents (Batch Manufacturing Records-BMR's, Batch Packaging Records-BPR's, Validation Protocols-IQ, OQ, PQ & Reports, Stability Reports). * Produced and maintained documents like deviations, change controls and CAPA in compliance with cGMP regulations. * Acted as a part of investigating team for both laboratory as well as manufacturing investigations, thereby gaining experience in documentation of Root Cause Analysis RCA, CAPAs and change controls. * Responsible for archival of all kinds of technical documents belonging to the production, manufacturing and quality control departments. * Gained immense experience with handling all kinds of documentation at the time of audits mainly with SOP creation, revision, change controls, distribution etc., * Acted as a bridge between QC, QA and regulatory departments to help with effective communication as well as to maintain records of files transfer between the departments. * Response to the Queries raised by regulatory authorities. * Coordinating with other departments (SMEs) in obtaining documents for compilation affecting company's products. * Maintain current knowledge of international regulations and standards. * Performing additional tasks or special projects as assigned by the General Manager from time to time upon requirements like training other employees on various SOPs, making presentations, preparing questionnaires etc. Quality Control Analyst, June 2012 - May 2014 Bharat Biotech International Limited. Responsibilities: * Analysis of Bio-therapeutic products namely Regen D (epidermal growth factor), Biogit (Saccharomyces Boulardii) by various methods like SDS PAGE, ELISA, Protein estimation and also usage of various kits (BCA assay kit, Invitrogen kit) for various analytical procedures. * Development and Validation of various analytical methods used in analysis of samples (finished product and bio in-process samples). * Research & Development experience in development, optimization and validation of various methods and procedures. * Well experience in all areas of Quality Control Department and documentation. * Responsible for operation maintenance, validations, calibration checks. * Documentation of analytical reports from raw data to final reports for approval till stage of batch clearance.
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