Gaurav CVCL
- 1. Dear Sir/Madam, I am Gaurav Soni M. Pharm. in Pharmaceutical Chemistry with honor degree having cumulative 7 years of pharmaceutical industrial exposure currently working as a Senior Research Associate in Intas Pharmaceuticals Limited, Ahmedabad (Astron Division) in Regulatory-QA department since 23/05/2013 to assist Qualified Person (QP) to release batches in various European Countries. Earlier I have worked in Lupin Limited for 3 years 2 months as an Executive QA-RA in Indore plant from 15/03/2010 to 13/05/2013. I am also having 1 year of marketing experience as a Scientific Promotion Executive in Glaxosmithkline Pharmaceuticals Limited. I have been particularly interested in learning the Regulatory aspects which will improve my pharmaceutical knowledge now wishes to develop my career in that direction. Please find an enclosed copy of my Curriculum Vitae. I would wel-come the chance to work as a member of a dynamic team where I could make a significant contribution while developing my skills yet further I would be happy to show you a portfolio of my work. So if there is any vacancy in your esteemed organization matching to my profile, please make a call or send me a mail for further communication. Technical Skills: European Countries Query Handling Approval and assessment of Change control Module 3 Dossier Preparation CMC Documentation for DRA Submission MHRA Compliance Documentation Assisting QP for Batch Release in UK APQR Preparation Based on Importing Results Market Complaint Handling Faced USFDA, MHRA and TGA Audit Total Pharma Experience : 7 Years Notice Period : 90 Days Current CTC : 6.7 Lacs/Annum Expected CTC : As Per Norms
- 2. GAURAV SONI Contact: +91-7405667612(Current) / 0761-6529950(Permanent) E-mail: gaurav13101984@gmail.com / gaurav13101984@yahoo.co.in Seeking challenging assignments in Regulatory Affairs Department with a growth oriented organisation of high repute Professional Snapshot A dynamic individual with competent and diligent professionalism with cumulative 7 years of pharmaceutical work experience having excellent exposure for Regulated market with top generics of Injectables, Bio-similar Products and Oral Solids specialty organizations. Currently working with Intas Pharmaceuticals Limited (Astron Division), Ahmadabad as a Senior Research Associate in Regulatory-QA Department. I firmly believe in the principle of commitment for a cause with dedication and determination. Quick decision making with rationale approach along with excellent situation handling by sensible presence of mind. Last worked with Lupin Limited, Indore as a Quality Assurance Executive. Responsible for the Preparation of regulatory submissions within well defined time frames, in compliance with standard operating procedures and regulatory requirements. Preparation of high-quality CMC documentation for Health Authority submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring regulatory compliance, meeting agreed upon timelines. Have hands-on experience plant activities viz. Production, Quality Control, Quality Assurance / Compliance, Documentation, Processes, Audits, Inspection and system in pharmaceutical industry like change control management, deviation etc. Worked with different type of dosage form i.e. Biological Product, Oncological Parenteral Injection, Solid Oral like Tablet, Capsule and Oral Contraceptive pills (Active+Inert Concept). Possess highly motivated and positive attitude towards life along with focussed approach. Extinguishly able to work individually or as a team member with equal ease and sincerity. Possess exceptional team spirit thereby helping in easy achievement of organisational and personal goals. Exceptionally organised with a track record to demonstrate creativity and having ability to take self initiative to achieve smart objectives and goals. An effective communicator with an excellent relationship building and interpersonal skills.
- 3. Current Job Responsibilities (From Jun-2014 to Till Now) Supporting compilation of documents pertaining to Quality Module of eCTD of dossiers for submissions in US, Europe and compilation of annual reports. Post Approval Compliance like assessment of Change control, Deviation and accordingly submission of variation/change to the Agency. Review of submission related documents such as Product development report, BMR/BPR/PVR, Analytical Reports, validation reports, Technology transfer, stability reports for Injectable and solid oral products, to ensure all problems are identified and addressed concurrently. Supporting for NDAs/ANDAs/Dossiers for Injectable drug products for submission to USFDA and European agencies in accordance with current regulations. Review of post approval changes (administrative and quality) i.e. variations (Type IAIN, IA, IB and Type II) and handling of post marketing submission. Collate information and prepare the post approval submission, variations and safety reports during the life cycle management of the product. Ensuring that batches of medicinal product have been manufactured and assembled in compliance with the EU legislative requirements. Preparation and review of APQR (Annual Product Quality Review Report) for UK site including plant COA comparative trending. Assessment and approval of Change control with respect to regulatory submission and product quality. Cross verification of plant change controls with the current Market authorization variation and ensuring their implementation within time limit. Responsible for documents review of new product introduction for product launch to new country for existing product. Co-ordination with internal as well as external counterparts, manufacturing units and other departments. Resolving QP Issues from the batch document related to market complaint, deviation, stability data and Qualification status. (From May-2013 to May-2014) Ensuring Manufacturing Authorisation requirements for medicinal products have been met for the batch concerned. Review of documents especially to assist QP (Qualified Person) for batch release in UK. Review of data Loggers readings for received shipment in UK. Principles and guidelines of GMP as interpreted in the EU Guide to GMP have been followed.
- 4. Necessary quality assurance checks and tests have been performed, and account taken of the assembly and packaging conditions, including a review of records. Changes or non-conformances in assembly, packaging or quality control are dealt correctly. Query handling related with batch records, variation, mock-ups and art work along with co- ordination for Batch release activities. Ensuring regular audits, self-inspections and spot checks are being carried out by experienced and qualified staff as per intended job responsibilities. Reviewing Batch Record documents with reference to RTD for the market specific requirement for batch release. All associated documentation has been completed and endorsed by suitably authorised staff. Review of batch document, in-process COA and finished product COA with RTD. Previous Job Accountabilities From 15/03/10 to 13/05/13 with Lupin Limited, Indore as an Executive QA-RA. Module 3 Dossier Preparation & Ensuring adherence and compliance with applicable guidelines ICH, cGMP. Supporting regulatory CMC filing for meeting the regulatory requirement of USFDA, MHRA and TGA. Successfully faced USFDA, MHRA, TGA and SANDOZ Audits at Lupin Limited, Indore, M. P. Review of BMR and BPR after manufacturing and packing to ensure compliance to DRA submission. Preparation and review of SOPs, Hold Time Protocols and Reports including Process Validation Reports. Monitoring and review of Quality system documents i.e. OOS, OOT, Deviation, Change Control etc. Review of Qualification & Validation documents i.e. IQ, OQ, PQ, TBPQP, TBPQR etc. and Stability data grids. Investigated the recall batch of finished product of steroids in minute quantity with an excellent documentation to ensure consistent premium quality of the product and their safety and stability studies are carried out for secured and optimized therapeutic efficacy. 1 Year with GlaxoSmithKline Pharmaceuticals Ltd. at Ahmedabad as a Medical Representative. Promoting premium quality antibiotics including world’s No.1 antibiotic Augmentin on ethical and scientific basis by visiting super speciality Doctors to achieve the targets successfully.
- 5. Academic Credentials M. Pharm. Nargund College of Pharmacy, R.G.U.H.S. Bangalore, Karnataka in June 2009 (P. Chem.) And secured 77.2% Marks. B. Pharm. G.R.K.I.S.T. Jabalpur, R.G.P.V. Bhopal, M.P. in June 2006, Secured 66% marks. XII Saraswati H. S. School, Jabalpur, M. P. Board in March 2002, Secured 73% marks. X Saraswati H. S. School, Jabalpur, M. P. Board in March 2000, Secured 70% marks. Extracurricular Achievements Professional achievements: Supported and Participated in Review Team during Regulatory and Consultant inspections to check application integrity. Faced MHRA Audit at Intas Pharmaceuticals Limited, Ahmedabad in 2016 and 2013. Faced USFDA Audit at Lupin Limited, Indore (M.P.) in 2012. Faced MHRA Audit at Lupin Limited, Indore (M.P.) in 2011. Academic achievements: Stood 2nd in the college for 77.2% in M.Pharm session among all branches. Won 1st prize in Pharma quiz during National Pharmacy Week at college level. Registered Pharmacist in M.P. State of Pharmacy Council. Academic Projects & Dissertation Handled M. Pharm. (Pharmaceutical Chemistry) Project Title : Synthesis of Fluoro-Pyrazole Compounds for their Biological Activity. Description : The project involves synthesis of derivatives of Fluoro-Pyrazole compounds And their characterisation by UV, IR and NMR. Duration : 6th Jul’08 - 30th Jun’09. Personal Portfolio Date of Birth : 26th September, 1984 Marital Status : Married Current Address : A-503, Shlok Parisar, Near Gota Bridge, Gota, Ahmedabad-382481. Permanent Address : 1550, Navnivesh Colony, Ganga Nagar, Jabalpur-482003, (M.P.) Linguistic Abilities : English and Hindi Interests : Music, internet surfing, playing chess, visiting places Personal Traits : Sincere, Team Player, Responsive and Ambitious.