Job Title: ASSOCIATE (AA/ 1A level) Reporting to: Team Leader Function: Operations(CCC & CMC) Line of business: Medical Devices & Pharma Services Work timings: Only night shifts Work Location: Kolkata (candidate who is out of transport boundary will have to relocate to Kolkata vicinity as per our transport team guidelines) Department: Wipro DOP Hierarchy in Wipro: Associate (AA) then Team Leader (B1) then Group Leader (B2) then Senior Group Leader (B3) then Manager (C1) then Senior Manager (C2) JOB DESCRIPTION OF A COMPLAINT SPECIALIST PRINCIPAL RESPONSIBILITIES: Multitask which includes pulling up of relevant documents and responding satisfactorily and immediately Provide expertise in receipt and processing of medical device complaints via incoming calls, faxes, and emails, serving as the primary point of contact. Answer and process all incoming calls and inquiries from customers, sales reps, and various employees of CLIENT in regards to returns, product complaints, and special projects as required. Accurately enter complaint information into complaint handling system GCMS-TW in a timely manner and in accordance with the company¿s complaint policy and procedures. Create, maintain, and adjust all return authorizations within SAP for product complaints and field actions and create replacement orders as required. Respond to inquiries and assist customers and sales representatives regarding Boston Scientifics¿ complaint and returns policies. Owns Complaint handling process from Complaint receipt to record closure Ensures timely processing of Complaints Assesses Complaints (events) for MDR reportability and submits reports to FDA U.S. customer Complaint communications Completes Good Faith Efforts (GFE¿s) for outcome/result of an Adverse Event and/or complaint sample return Maintains ¿As Reported¿ codes and Rationale Codes Reviews field service records for Complaints Collaborates with Complaint Investigation Sites (CISs), Medical Sciences, Safety Surveillance, Marketing, and Regulatory Helps with complaint data collection for PIRs. Follows specific, detailed instructions. Ensure that all company information which includes customer information are kept confidential and secured Maintain and follow proper compliance to quality system regulations (FDA Code of regulations 21CFR part820). Establish and maintain complete complaint files and databases for all customer complaints, according to complaint, FDA, and international regulatory and complaint requirements related to the complaint system process. Review all received complaints to identify if a complaint is reportable under the FDA and international requirements. Document the decision process for all complaints received. Complete and submit the MDR¿s and international regulatory reports as needed. Perform job duties with general instructions. Identify, initiate, and /or perform corrective action activities (CAPA, Non-conformance) in response to trends and patient based risk. Keep oneself updated, aware of, and compliant to all Company policies and procedures which include Information Security Management Systems Keep all company information that includes customer information confidential and secured. SKILLS REQUIRED: Strong Analytical and communication skills Good computer knowledge, mainly MS Office. Good typing speed Excellent telephonic and listening skills Strong team player and interpersonal skills Flexible for the shifts Demonstrated Customer Service Skills Ability to think critically to determine the type of questions, which need to be asked to gather necessary information Strong written skills, with the ability to write narratives related to the complaints Knowledge in Call Monitoring Tools/Real Time Adherence is a plus Able to handle inbound calls/process emails and make outbound calls effectively Ability to understand customer requirement
Roles and Responsibilities
Experience Range: 0-1 Years
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristic protected by law. Any complaints or concerns regarding the recruitment, application or hiring process should be directed to our Ombuds group www.wiproombuds.com. Any US applicant can also call our hotline at 1-866-921-6714. Applicants outside the US can request the applicable hotline number via email via the Ombuds group.
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