1. ARAVIND KUMAR SONI
Town & Post-Koraon, Dist-Allahabad (UP), 212306
Contact: +91-8146535301; Email: aravindsoni.soni@gmail.com
HEADLINE
Production and Quality Management Professional – Biotechnology
SUMMARY
I am a competent Production & Quality Management Professional with core strengths in Production Operations, Method/Product Developments, Quality Assurance Techniques, Techno-Commercial launch and implementation of Standard methods across the biotechnology sector. Currently spearheading as Sr. Executive in Upstream Process (Biotransformation of Thiocolchicine to Demethyl Thiocolchicine) with Quad Life Sciences Private Ltd, Derabassi, Punjab, I manage all aspects of quality control operations with key focus on implementing quality management systems and manufacturing practices. With excellence in Environmental Monitoring, Autoclave Revalidation, Qualification Studies and Quality Management System, I have influenced cross-functional teams and led peers to resolve barriers across multiple processes. My objective is to develop innovative methods for increasing productivity and improving service workflow. Well versed in implementing, reviewing and updating quality systems and procedures, I am adept in managing widely-divergent, simultaneously occurring processes by using strong organizational skills and innovative problem solving abilities.
Equipped with ability to excel under diverse and challenging environments, I intend to add value to all stakeholders and meet the expectations and demands of the organization. I have contributed to operation and maintenance of biologics processes, equipment and facilities to ensure compliance with international cGMP regulations and standards. I have actively participated in various audits like WHO, NRA, EU-GMP and US-FDA. Well versed with DCS, PLC and SCADA control systems, I am skilled in microbial fermentation, seed preparation, inoculation and conducting in process testing during batch processing. With established credibility in enhancing the quality-centric image of the company, I intend to expand my footprints in this domain and make a visible contribution to organizational growth.
SKILLS
Production Management • Quality Management System • Audits • Quality Assurance • Technical Evaluation • Requirement Gathering • Technical / Quality Support • Microbial Fermentation • Batch Processing • Client Interaction • Technical Solutions • Operation & Maintenance • Analytical Skills • Documentation • Preparing SOPs

2. EXPERIENCE
Sr. Executive in Upstream Process (Biotransformation of Thiocolchicine to Demethyl Thiocolchicine) with Quad Life Sciences Private Ltd, Punjab (Since Mar’14) Spearheading QA operations with final accountability to minimize rejections and resolve quality related issues promptly to enhance quality-centric image of the company. Ensuring compliance of quality management system including filling of incidents, raising of deviations, change control, CAPA and other quality system. Ensuring all the products have clearly defined specifications with careful & sophisticated quality control measures in compliance to the international standards. Actively involved in environmental monitoring, autoclave revalidation and ultra-low temperature deep freezer revalidation. Executing functions related to qualification studies (Installation, Operation Qualification). Involved in validation, operation and maintenance of biologics processes, equipment and facilities to ensure compliance with international cGMP regulations and standards. Executing campaign change activities and line clearance activities in a multi product facility including campaign change from PRP of Haemophilus influenza type B vaccine to Polysaccharide of Streptococcus pneumonia and vice versa Supervising all the records of equipment, solution, culture media, material and process to ascertain their status prior to use. Contributing to microbial fermentation, seed preparation, inoculation, thermal mapping and fermentor (750L fementor Bioengineering) validation studies Conducting in process testing during batch processing and CIP/SIP of lab scale and large fermentors (30L,60L,750L,2.5KL,20KL) Preparing SOPs and batch record/cleaning record and updating documentation as per WHO/cGMP guidelines
Scientific Officer in Upstream Process (Haemophilus inflemzae Typeb vaccine Production) in Panacea Biotec Ltd, Chandigarh (Jul’12 – Mar’14)
Chemist in Fermentation (2.5KL, 20KL Fermenters), Concord Biotech Ltd, Dholka, Ahmedabad (Oct’10 – Jun’12)
MAJOR ACCOMPLISHMENTS Ranked 6th in All India Combined Entrance Examination for M.Tech conducted by JNU Delhi on behalf of the Department of Biotechnology (DBT), Government of India. Credentials of qualifying GATE in 2007 Faced various audits including WHO, NRA, EU-GMP and US-FDA Participated in joint Indo-UK Conference on Biotechnology at Anna University Chennai (2008 and 2009) Participated in joint Indo-Russian Conference on Biotechnology in 2008 (on the Occasion of 50th anniversary of Indo-Russian collaboration). Participated in National science festival-98 (assay, science questionnaire) organized by the District Science Club, Allahabad

3. EDUCATION/ CERTIFICATIONS
M. Tech. (Biotechnology) from Anna University, Chennai
B.Pharma from M.J.P.R.U, Bareilly