Responsibilities Performs microbiological testing in accordance with standard procedures Collect and analyze data to draw conclusions and recommend actions Apply appropriate methodologies and data interpretation techniques to assist in overcoming technical difficulties and promote continuous improvement. Maintains the laboratory quality assurance systems to assure validity of data Perform or assist vendor in the installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) of laboratory instruments and equipment. Maintain accurate, up to date and concise laboratory records Supports a microbiological sampling and testing program for water, raw materials, work-in-process (WIP), environmental samples & finished products at the facility. This plan must be based on QS 023. Understand and use basic laboratory safety equipment and instructions, precautions in handling and disposing of biological materials, in accordance with local environmental regulations. Troubleshoot basic instrument or methodology problems.     Qualification & Experience Master's Degree in Microbiology or related biological science. At least 5 years of industrial experience (Personal Care, Pharmaceutical, Food, and Environmental). This experience should include working in a manufacturing lab with exposure to plant floor micro control programs.  

Qualification & Experience B. Pharm./M. Pharm./M.Sc 01-02Years as CRA   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience B. Pharm./M. Pharm./M.Sc. 04-06 Years in Vendor Qualification Auditing   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Following will be the responsibilities of position holder: Compilation of ANDAs and 505(b)(2) applications (pIND meetings, IND submissions, Brand Name submissions) with USFDA Experience in submission of pre-ANDA meetings for complex products with USFDA Review of DMFs of complex peptide drug substances Ensure timely response submission for ANDA deficiencies i.e., IR, CRL and DRL Ensure Labeling compilation, including SPL and side by side comparison against RLD labels with highlighted annotation of changes QBR compilation for drug substance and drug product; Sterility assurance QBR Experienced with handling drug device combination regulations and understand the requirements for submission of Threshold Analysis report and Human Factor Engineering studies protocols and reports. Review and approve of Design History File Controlled correspondence submission with the regulatory authorities for bioequivalence recommendations & inactive ingredient levels and Q1 and Q2 sameness evaluation which are essential during the product development stage before the submission of an application Supplements filling for addition of alternate facility and CMC related changes, e.g., PAS, CBE-30 and CBE-0 Life cycle management of products & approving the change controls and ensure product continuity through filing and timely approvals of supplements. Support the continuity activities through co-ordination with various stakeholders Approval package compilation and provide support for lunching of the approved ANDA product Ensure product compliance with respect to approvals and regulatory requirements Tracker management-Maintenance of ANDA filing status, deficiency, approval, labelling and new launch status   Qualification & Experience  B.Pharma/ M.Pharma 4 to10 Years Of experience    

Responsibilities Able to perform the reactions (mg to gram scale) & work independently under the guidance of the leader. Independently support the scientific team with instrumentation and equipment operation and maintenance. Able to understand & interpret various instruments like NMR, Mass, HPLC. Instrument purification like Combiflash, big columns, column packing. Deciding the mobile phase for purification. Independently handling all type of glassware assembly arrangement, reaction reagent charging, maintaining temperature, nitrogen etc. Should be able to understand the written instruction from the scientist including patents and reprints where procedure highlighted by scientists. To train and support the team members. Meticulous Documentation & proper data management. To maintain the record book of the work done like purification or reaction.   Qualification & Experience 2 to 4 Years of experience working in the CRO industry Strong organisational, project management and problem-solving skills with impeccable multi-tasking abilities. Exceptional interpersonal skills. Friendly and professional demeanour. Ability to write reports and prepare spreadsheets and presentations. Excellent organisational skills with an ability to think proactively and prioritise work. Proactive, highly motivated with a "can do" attitude. Strong and accurate attention to detail. M.Sc. Organic Chemistry  

Responsibilities Visit Doctors, Pharmacists and Hospitals in order to inform on products according to the marketing strategy and with the frequency and number of impacts approved for each segment of doctor. Build up and maintain a relationship with these stakeholders. Assist to Scientific congresses determined by the company. Classification of doctors and other stakeholders of the area according to the segmentation and targeting criteria. Proposal of new doctors to add to the files, changes or removals. Track the prescription habits of the doctor, check his/her consideration of our products, ensure which is the prescription potential and his/her influence in other doctors. Inform in an accurate, updated and according to the company's strategy about our products: use of marketing material, clarification of doubts and concerns of doctors about the products, opposition to objections, advantages compared to the competency. Ensure that other departments complete this information to the doctor if necessary. Obtain information from the market about the doctors' concerns on our products, the competence and test our own marketing strategy and materials. Obtain information about possible public tenders, launchment of competence products, cost containment measures, Health authorities possible instructions to doctors… Transmit this information. Propose activities in their territory (invitation to congresses, participation of doctors as lecturers, organization of clinical sessions…) that helps to promote our products always in compliance with ethics standards and ensuring the Return on Investment. Organize the proposals approved according to the budget assigned. Manage the budget assigned ensuring the return of investment Inform timely and in manner about the daily activity and the next weeks planification and present on time expenses report or any other requested by the company.     Qualification & Experience University degree or equivalent is preferred Background in Science, biology, medical and pharmacy is preferred Proficiency in computer skill Good communication skill  

Responsibilities Visit Doctors, Pharmacists and Hospitals in order to inform on products according to the marketing strategy and with the frequency and number of impacts approved for each segment of doctor. Build up and maintain a relationship with these stakeholders. Assist to Scientific congresses determined by the company. Classification of doctors and other stakeholders of the area according to the segmentation and targeting criteria. Proposal of new doctors to add to the files, changes or removals. Track the prescription habits of the doctor, check his/her consideration of our products, ensure which is the prescription potential and his/her influence in other doctors. Inform in an accurate, updated and according to the company's strategy about our products: use of marketing material, clarification of doubts and concerns of doctors about the products, opposition to objections, advantages compared to the competency. Ensure that other departments complete this information to the doctor if necessary. Obtain information from the market about the doctors' concerns on our products, the competence and test our own marketing strategy and materials. Obtain information about possible public tenders, launchment of competence products, cost containment measures, Health authorities possible instructions to doctors… Transmit this information. Propose activities in their territory (invitation to congresses, participation of doctors as lecturers, organization of clinical sessions…) that helps to promote our products always in compliance with ethics standards and ensuring the Return on Investment. Organize the proposals approved according to the budget assigned. Manage the budget assigned ensuring the return of investment Inform timely and in manner about the daily activity and the next weeks planification and present on time expenses report or any other requested by the company.     Qualification & Experience University degree or equivalent is preferred Background in Science, biology, medical and pharmacy is preferred Proficiency in computer skill Good communication skill  

Qualification & Experience GNM/B.Sc (Nursing) 2-3 Years of experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Must have sound knowledge about pharmaceutical industry and experience in pharma international business development. Responsible for International business development & Sales activities by establishing new distributors and existing clients (Merchant Exporters & Overseas Direct Clients) for ROW / Emerging Markets (South East Asia, West Africa, CIS). Responsible for Identifying new potential markets, new products lien up by market research and export data analysis. Strategy & Budget planning to open new countries. Coordination with costing team for quotation and price negotiation as per customer feedback and conversion of inquiries to orders. Coordination with regulatory team for filing of new dossiers in countries, samples and query replies for product and plant registration. New order generation, order execution and coordination with Manufacturing team / plant team to ensure timely delivery of orders. Shipment line up by coordination with client and with freight forwarders, pre and post shipment activities and documents (Proforma, Invoice, Packing List, BL Finalization and payment follow-ups). Coordination with Banks for payment inward and shipment documents submission to close the transactions. Ensure to complete all provided task related to work profile within stipulated timeline by coordinating with all departments. Sales database generation, monthly, quarterly & annually sales report generation and review meetings with management to make strategies. Exhibition and representation of company in domestic and international exhibitions and BSMs like iPhex, CPhI, Pharmexcil Tours by setting up booth and attending buyer seller meet. As per requirement ready to Travel extensively to meet clients in India & International. Other work related to this profile.     Qualificaion & Experience B. Pharma / BSc / MBA / M. Pharma Experience – Minimum 3-5 Yeas in same field    

Responsibilities The RA Executive shall report to the Head of QA/RA, and is responsible to assist him in the following areas: Leading new products registration and license renewal in various countries Compliance for international as well as local regulations for various class of medical devices To Lead QA/RA team and ensure quality SOPs within the company Have the joint responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product life cycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment Oversee maintenance of product quality and compliance through the Quality Assurance functions as well as management of the Quality Management System and compliance processes Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects Keep abreast of International legislation and guidelines of current product line in India Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements Provide product specific Regulatory strategies to mitigate risk; works in conjunction with production, RA & QA team to provide advice on process and labeling changes Review of SOPs, BPRs, specifications and change control to ensure compliance Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks Drives resolution of issues, communicates issues, impact and outcomes to the management team Responsible for ensuring compliance to the submission standards, procedures and policies in India Support Commercial Department in business development such as product evaluation and pre-launch activities Support Marketing/sales department for product review, product function training, catalogue preparation, content management, field queries resolution etc     Qualification & Experience More than 2 years of experience in technical documentation, regulatory affairs and quality assurance in the medical device industry Bachelors degree in relevant field. Master's is desirable Ethical behavior and high level of integrity