We are offering jobs at packagingconnections.com | Career in Packaging Services in India

Online Packaging Reports

Packaging Suppliers

Packaging Buyers

Packaging Professionals

Packaging User Companies

Packaging Softwares

Others

Sanex Packaging Website is a very interective, Motivative, Innovative and giving very excellent Idea for New Package Development Era. This Web also help to Drive new packaging materials development ac....

Dhirendra Singh
India Glycols Limited, Delhi

CAREER DETAILS


	Back
	Heading : Expereinced packaging and quality person for medical devices & pharmaceuticals
	Posted Date : 05-Dec-2007
	Type : Agencies and services
	Country : India
	Description :
	Dr. Vijai K Sharma Villa No. P 28, Ashiana Silvercrest, Uppals Southend, Sector 48, Sohna Road, Gurgaon, Haryana 122010, India Mobile: 91 9899108000; Res: 91 9818168258 Email: vijaiksharma@gmail.com, vijai_k_sharma@rediffmail.com Career Objective Challenging Assignment in Regulatory Affairs/ Quality Assurance/ Product Development with a high growth oriented organisation Synopsis • A result oriented professional with over 20 years post qualification experience in the areas of Regulatory Affairs, Quality Assurance, Product and Packaging Development • Development of Various Products, Constituent and Packaging Materials for International regulated markets • Development of Quality Management Systems compliant to ISO 9001:2000, ISO 13485:2003, cGMP FDA, MDD/CE and GHTF requirements; • Achieving high standards of customer satisfaction based in US and Europe; • Regulation of Medical Devices and Healthcare Products in US, Europe, Australia, Russia, Brazil, Argentina, China, Korea, Japan, Philippines, Singapore, Thailand, Taiwan markets; • Exceptional Business Development, Relationship Building, Team Leadership and Inter-personnel skills • Experience of developing and working in various ERP modules including SAP and use of statistical tools for monitoring and enhancing the overall efficiency and profitability of the organisations. Career Highlights Since 2004 with M/s Jai Surgicals Limited, India as the Director (Quality Assurance/ Regulatory Affairs) (An ISO 9001:2000, CE, ISO 13485:2003 Certified and Health Canada, US FDA, TGA Australia, MHRA, UK Registered Organization). It manufactures surgical blades, disposable scalpels, skin graft blades, stitch cutters, safety scalpels, Biopsy punches healthcare devices. Its products has well established international quality and 100% export to more than 70 countries with geographical reach to Europe, USA, Canada, Japan, Korea, Australia, Argentina, Brazil, Singapore, Thailand, Russia, Taiwan, South Africa etc.) Key Tasks Handled: Quality Assurance and Product/ Packaging Development • Certification of multiple manufacturing sites for ISO 13485:2003, ISO9001:2000, ISO 13485:2003 (Under CMDCAS) and MDD/CE • Use of Six Sigma and statistical tools for monitoring and improvement of Processes and Performance of Products • Project start-up and Process Validations in compliance with Global Harmonization Task Force (GHTF) and US FDA guidelines • Supplier and third – party manufacturing quality management • Development of New Medical Devices, Raw and Packaging Materials for global markets • Risk Management, Internal and external Audits, GMP compliance, Clinical Trials, Technical (DMF) and Design Files Development and Updation • Development of Process and Product Specifications, Benchmarking of test methodologies and equipments Regulatory Affairs and Statutory Compliance • Development and Implementation of Regulatory, Risk Management and Product Safety Strategy of new and existing products in compliance with US FDA, CE, Health Canada, TGA Australia and MHRA, UK requirements • Quality Assurance documentation for US, Europe and Asia based customer organizations (BD, Cardinal Health, Tyco Healthcare, BBraun, Artsana, Dahlhausen, Molecular Metallurgy, Cypressmed, Ansell, Nitcho, Nopa etc.) • Post market Surveillance (Adverse Drug Reactions) and customer complaint redressal of exported devices Notable Accomplishments:  Start up of new manufacturing facility with Regulatory Certifications(for MDD/CE, ISO 9001:2000 and ISO 13485:2003), Process validations and Associated Risk Management  Development (Product and Packaging) and Regulation (product safety evaluation, product registration and certification) of 4 new products in US/ Europe market within last two years 1997 to 2004: Worked with Becton Dickinson as Manager (Quality Assurance and Materials Development Head) (An ISO 9001:2000, CE, ISO 13485:2003 Certified and CDSCO India and SDA China registered Multi-national Organization: 100 % subsidiary of Fortune 500 Organization- BD USA). It manufactures Auto-disable Syringes, Hypodermic Syringes, Hypodermic Needles, Intravenous Catheters, Alcohol Swabs, Blood Collection Tubes and markets various diagnostic equipments and reagents). Key Tasks Handled: Quality Assurance and Regulatory Affairs • Start-up of the India manufacturing plant by obtaining WHO-GMP and manufacturing licences • Regulation of various health care products to India, China, Australia, Philippines, Sri Lanka, Bangladesh and Singapore markets • Worked with CDSCO (Central Drugs Standard Control Organization) and BIS (Bureau of Indian Standards) for development of various regulations in the country • Completion of Clinical Trials and Product Safety Evaluation of various new devices • CE, ISO 9001:2000 and ISO 13485:2003 certification of the manufacturing plant • Development and quality audits of raw and packaging material suppliers and third-party manufacturers • Lead customer handling system for the organization • Potential Hazard Analysis and Risk Management of regulated Medical Devices • Represented organization/ provided technical support for legal cases at Drugs Controller Office and Consumer petitions • Technical back-up support/ Induction training to sales and marketing teams/ Filing tenders in South Asian countries • Audited cGLP certified laboratory – BD Worldwide Medical Toxicology (BD WWMT), USA Products and Materials Development • Validation (Regulatory and Corporate Compliance, Product Efficacy, Biological Safety, Shelf Life Evaluation and Associated Risks Management) of cost effective products, raw and packaging materials for Asia-pacific region manufacturing • Compliance of Devices, Packaging and Labelling for multiple countries and corporate regulations • Trainer for materials development (cross-functional) teams of BD Pakistan, Singapore, India, Korea and China • Technical Negotiations for Raw and Packaging Materials Notable Accomplishments:  Lead Asia-pacific team for cost-effective materials development and Validation for seven manufacturing facilities in the Asia-pacific region achieving savings up to 2MM USD in a year  Developed Destruclip, Alcohol Swab, Intravenous Catheter and other products specifically for AP region markets  Established Supplier Quality Management System for the manufacturing facilities and Asia- Pacific region suppliers  Established WHO-GMP and ISO 13485:2003 complaint QMS for India location 1995 to 1997: Worked with Shriram Applied Radiation Centre, New Delhi, India as Facility head (An ISO 9001:2000, ISO 13485:2003 Certified and Drugs Standard Control Organization and Atomic Energy Regulatory Board licensed contract gamma sterilization research centre). It sterilizes pharmaceutical and healthcare products, medical devices, ayurvedic products, spices etc. It is first gamma sterilization facility in private sector licensed from Atomic Energy Regulatory Board and second largest in capacity in India). Key Tasks Handled: Quality Assurance and Operations • Regulatory Compliance of gamma sterilization facility to International Atomic Energy Board, Vienna and Drugs Controls Directorate, India requirements • Validation of various pharmaceutical products and medical devices for Gamma sterilization stability and intended shelf life • Process validation and operations as per ISO 11137:1995 and EN 552:1991 for parametric product release of gamma sterilized devices and healthcare products Notable Accomplishments:  Lead business development of gamma sterilization facility (Revenues tripled in a span of 2 years) by developing low dose gamma sterilization process for ayurvedic medicines and radioactive contamination testing of food, spices and devices  Developed Gamma Sterilizable Packaging Bags for Bulk Drugs Since 1984 to 1995: Worked with Shriram Institute for Industrial Research, New Delhi, India as Research Associate/ Scientist Key Tasks Handled – Project Management of Multi-disciplinary projects for development of Industrial Products and Processes; Participated in Development of Quality Assurance system for the organization Notable Accomplishments:  3 Patents on process development of gamma sterilizable blood bag systems  Development of Phosphonitrilic elastomer for Vikram Sarabhai Space Centre, India  Development of Gamma Resistant Polypropylene for microbiology applications Academic Qualification Year Qualification Workplace 1991 Ph. D. (Chemistry) Delhi, India 1983 M. Sc. (Chemistry) Agra, India 1981 B. Sc. (Zoology, Botany, Chemistry) Agra, India Certification  Lead Auditor ISO 9001:2000 (Griffin A Associates, UK)  Successfully completed Supplier Quality Management of BD , USA  Successfully completed Sterilization Technologies (DNV, India)  Successfully completed Ethical Fitness Workshop of BD , USA  Managing Performance Excellence Workshop of BD, USA  Approved Resource Person for Regulations pf Medical Devices and Pharmaceutical Products – CDSCO (Central Drugs Standard Control Organization), India  Approved Radiation Worker, Atomic Energy Regulatory Board, India Training and Memberships Attended various trainings like:  Six Sigma Green Belt Training, Becton Dickinson USA  Member – Technical Committee, BIS (Bureau of Indian Standards)  International Regulation of Devices, Becton Dickinson USA  Quality Assurance training at BD USA, Spain, Singapore and China Centres  Process Validations Training at Becton Dickinson, India IT Skills SAP (QM, MM and SRM Modules), Lotus, Minitab (Statistical Software), EAN/ UCC/GS1-128 Article Identification System (Product Bar-coding) and Microsoft Office Tools Date of Birth: 1st July 1962

Link To Us | Policy