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Customer Medical Device

Location:
India
Posted:
November 08, 2018

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Resume:

Sathish Elumalai

• CELL: 887******* • E-MAIL: ac7m6d@r.postjobfree.com

OBJECTIVE:

An experienced, result-oriented associate working in Product Compliance area, who brings process knowledge and related business system expertise to the Organization. PROFESSIONAL SYNOPSIS:

• A competent professional with 2 years of experience in Logistics and Supply chain management.

• Proficient in handling all aspects of Europe and North America orders (Chemicals and Consumables)

• Expertise in ensuring safe delivery of chemicals to client sites along with ensuring the products meet the specifications of the customer

• Proficient in maintaining documents to ensure Customs & Excise clearances.

• Adept at supervising documentation processes as per specified norms and managing data updating process.

• Skilled in ensuring effective utilization of available manpower & resources and providing required customer support

• Ability to understand customer compliance request and provide suitable resolution by self or collaborate with internal / external customers, suppliers or stakeholders to provide resolution within the agreed turnaround time

• Responsible for creation, issuance and updating of product documentation which could include documents such as specifications, allergens, GMO, Labelling, Country compliance, Kosher, Halal, SDS, Nutritional information, Country of Origin and other regulatory documentation as needed.

• An effective communicator with analytical, problem solving & organizational abilities. ORGANISATIONAL DETAILS AND KEY DELIVERABLES:

VWR, Part of Avantor

DESIGNATION : Associate

DURATION : July 04th 2016 to till date.

• Working with VWR Regulatory & Global Data Compliance and making sure that VWR Orders are in compliant with different Regulatory and Compliance requirements of the specific regions.

• Prepare responses to Customer requests for information, such as product data, written regulatory affairs statements and questionnaires.

• Resolve documentation issues with collaboration of subject matter expert and technical staff.

• Knowledge in classification, identification of dangerous goods and Hazardous Materials Transportation.

• Releasing the blocked orders by performing regulatory checks (like Drug Precursors, Narcotics, Psychotrophs, Volatile Organic Compounds, Dual use goods, Chemical/Biological weapon precursors, Disinfectants. Etc.,) according to European regulations

• Review SDS for proper shipping name, PG, UN# and release freight for packing according to the hazardous regulations.

• Knowledgeable of Drug Enforcement Agency (DEA), Prescription Drugs, and TTB regulations.

• Knowledgeable of FDA and Health Canada drug and medical device regulations.

• Significant knowledge and exposure towards North American and Canada Regulation for Dangerous Goods

• Working with Data Compliance to review and update the documents periodically.

• Defining SOPs, SLAs and KPIs for ensuring smooth operations

• Handling and maintaining all the regulatory documents & daily calibration records and contributing in the developmental activities

• Develops relationship with key customers (internal and external) to assure appropriate communication and responses are provided

• Responsible for handling daily routine of regulatory inquiries from customers through lotus notes in a timely manner.

IT SKILLS:

• SAP Material Management (Purchase Order, Purchase Requisition, Inventory Management)

• MS OFFICE

• Internet Applications

HONOURS AND AWARDS:

• Received an Annual award as EXCELLER for the year 2017 for superlative performance, exceptional customer centric approach and drive towards excellence.

• Honored with a Certificate of Appreciation as the Star Performer award consecutively for four times in the year 2016-2017.

• Received appreciation from business owners for completing the Supplier Quality Program on time with timely manner.

TRAININGS ATTENDED:

• Special training on handling and modification on SAP especially for orders related to Animal and Human by products.

• Corporate training includes Corporate Ethics and Organizational behavior, Outbound

• Training in Team management, ISO awareness and telephone manners training, Excel basic and intermediate.

ACADEMIC QUALIFICATIONS:

• Graduate in B. Tech Biotechnology with 70% at Arunai Engineering College, Tiruvannamalai. From year 2012-2016

• H.S.C with 66% at A.C.S Mat.Hr.Sec School, Irumbedu from year 2011-2012.

• S.S.L.C with 72% at A.C.S Mat.Hr.Sec School, Irumbedu from year 2010-2011.

• Final Year project on “Prevalence pattern and Molecular characterization of Hepatitis A&E in and around Chennai” at King Institute of preventive Medicine and Research Center, Guindy. SKILLS:

• Willingness to Learn, problem solving and work within stringent deadlines.

• Ability to work in a group and time management.

• Confident, dedication and decision making skills PERSONAL DETAILS:

Date of Birth : 01.02.1995

Gender : Male

Father Name : G Elumalai

Nationality : Indian

Marital Status : Single

Languages known : English, Tamil

I hereby declare that the information above provided is true to the best of my knowledge. Date: Yours Faithfully

Place: (Sathish E)



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