Qualification & Experience B pharmacy / M pharmacy fresher candidates for Production Department for our Unit-2 plant  0 to 1 year  experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities To conduct Literature search and Patent search for assigned project. To procure raw materials (API / excipients), packaging materials and innovator samples in consultation with packaging/purchase department. To prepare application for form 29 and form 11 for the grant of manufacturing license for the purpose of Examination, Testing and Analysis and import of RLD. To perform pre - formulation and formulation development trials with QbD approach and therefore to develop a robust formulation.     Qualification & Experience M.Pharm (Pharmaceutics) with about 3 - 9 years experience in R&D product development with injectable product development that includes liquid, lyophilized and complex injectables.  

Responsibilities To prepare and assist in application for statutory requirements of Indian government regulations like – D&C Act & Rule   NDCT Rule 2019     Cosmetics Rules 2020    MDR-2017 Working knowledge of : CT-10, CT-12, CT-13, CT-21.   Qualification & Experience M. Pharm./ M.sc Experience and understanding of Quality Audits, Exposure of handling regulatory inspections. Expected Work Experience: 3 to 8 Yrs. in Domestic / US / EU market.  Expected Technical Qualification: Sugam portal & NSWS portal. CBN online portal experience is preferred.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"

Qualification & Experience B. pharm / M pharam Experience - 6 to 9 year in Documentation   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience  B. pharm Experience - 2 to 3 year in tablet compression formulation   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience  B. pharm / B.sc Experience - 4 to 5 year in OSD formulation   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Preparation of Documents for product COPP, MMC, FSC, Non conviction certificate etc. Grant/ Renewal of Manufacturing License. Grant/ Renewal of WHO-GMP Certificate, GLP certificate, GMP certificate etc. Grant/ Renewal of Loan Manufacturing License and all Kind of works related to FDA. Liaoning with the office of state drugs controller as well as Zonal CDSCO Offices for necessary drugs approvals to supports Indian and EM markets Relationship management with SLA and State Drugs Offices. Tracking of validities of all licenses and planning for renewal of the licenses. Daily updating of approval of data base. Preparation of Application for Export NOC from SLA. Preparation of Application for grant/renewal/ retention of Drugs Wholesale licenses. Preparation of applications for grant/renewal/ retention of Drugs Retail licenses. Provide necessary feed back to the central team based on day to day interaction with Regulatory Authorities. Follow up with CRI Kasauli regarding Drugs products and vaccines. Handling, review and approval of artworks. Preparation of documents and Expedite in approval of technical competent staff. Actively participation in all internal audits as well as country audits Actively participation in all Govt. audits SLA, CDSCO and other departments. Review and approval of GMP documents MFR, BMR, BPR etc. Preparation of dossier for product approval from DCG.   Qualification & Experience B.Pharma/M.sc Experience : 7-10 Yrs.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Technical knowledge of dialysis machine and other equipments. Well acquainted with the disinfection process of equipments. Knowledge of storage and cleaning. Aware of Infection Control processes   Experience Minimum Experience: 1-2 years  

Responsibilities Monitoring of IPQA activities Granulation, Compression, Coating, Capsule Filling, soft gel manufacturing, primary and Secondary Packaging Area. Monitoring Exhibit and Validation batches. Preparation and review of process validation and Hold time protocols and reports. Handling of Quality Notifications like Deviations, Change Controls, and its related Documents. Reviews and Approval of CAPA includes tracking, follow-up, reporting/trending and evaluating CAPA and action plan for effectiveness. Review of APQR (Annual Product Quality Review) based on the outcome CAPA shall be initiated. Ensure performance of self-Inspection/ Internal audits (Internal, External, Customer, Visits, and Regulatory) and assist with external quality system audits. Providing response for Manufacturing related regulatory audit observations.   Qualification & Experience 12-15 years in Quality Assurance specifically in IPQA   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities  Independently and confidently executes agreed dossier strategy. Independently manages multiple Rx and/or Vx project assignments simultaneously; assignments will range in complexity, but more complex work is expected. Independently completes data assessment to ensure dossier is fit for purpose. Identifies risks associated with submission data and information packages. Escalates issues with line manager that have business impact. May act as reviewer/approver for dossiers prepared by peers and identifies improvement opportunities for Regulatory processes, policies and systems. Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff. Understands internal/external Regulatory environment. Actively builds an organisational network (PSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing. Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK.   Qualification & Experience Minimum 6-10 years of experience Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines