Executive - Documentation

Executive - Documentation

Posted by Rubicon Research

Mumbai

Posted: imported by Jeevika

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MumbaiPosted: 3 weeks agoOpenings: 1Applicants: 100+Executive - DocumentationRubicon Research3.5417 ReviewsJob descriptionDear Candidate,! We are hiring ! Officer / Executive - Mfg Documentation ! Ambernath Plant !Role & responsibilities 1. Documentation & Protocol Preparation• Preparation and review of following documento Batch Manufacturing Records (BMR)o Batch Packaging Records (BPR)o intended batch BMR/BPR.o Process Validation Protocols/Reports (PVP/PVR)o Hold Time Study Protocols/Report (HTSP/HTSR)• Review and control of documentation to ensure consistency in manufacturing thereby reducing errors and deviations.• Drafting and maintenance of master records.• To ensure the document for production & packing activities adhering to cGMP norms and right at first time.2. Operation Efficiency• Streamline documentation workflows to improve productivity, traceability, and accountability across departments.• Submit BMR requests to QA and ensure that BMRs are available on the shop floor before starting production.• Provide suggestions with respect to documents for improving productivity, safety, and cost efficiency.• Monitor and control the manufacturing process with respect to documentation for each optimization, validation, and commercial batch, incorporating provided technical inputs and implementing documentchanges as and when required.3. Process Standardization• Review and control documentation to ensure consistency in unit operation, thereby reducing errors and deviations.• Communicate with the client or the TT/RA to obtain any missing documents or required information.• Ensure closing validation reports on time.4. Coordination & Cross-Functional Support• To co-ordinate Manufacturing, QA, QC, Warehouse, and Engineering to ensure smooth and timely execution of documents and closing of document revision change control.• Arrange all necessary documents prior to batch execution.• Co-ordinate with QA and cross-functional team to review the document and ensure that BMR/Documents are available on the shop floor before starting production5. Change Control• Initiate, track, and ensure the timely closure of Change Controls related to document revisions.• Assist in the preparation of data and documents for regulatory submissions and audits.Qualifications & Pre-Requisites • B. Pharm / M. Pharm• Knowledge of unit operations involved in manufacturing and packing ofsolid oral dosage forms i.e. Granulation, Blending, Compression, Coating,Capsulation, Packing etc. and nasal operations.• Basic knowledge of QMS/documentation (change control,document/Protocol/BMR/BPR preparation/review etc.)Additional notes: • Role is expected to work in all shifts. Interested candidate can share their resume on "[hidden]". Kindly do refer and share for better reach.RegardsRahul GuptaAssistant Manager - HRRubicon Research Pvt Ltd.Role: Production & Manufacturing - Other,Industry Type: Pharmaceutical & Life Sciences,Department: Production, Manufacturing & Engineering,Employment Type: Full Time, PermanentRole Category: Production & Manufacturing - OtherEducationUG: B.Pharma in Any SpecializationPG: M.Pharma in Any Specializationread moreKey SkillsSkills highlighted with ‘‘ are preferred keyskillsBPRBMRDocumentationManufacturingChange ControlPlantProcess ValidationAbout the companyRubicon Research InternetPharmaceutical & Life SciencesPrivateForeign UnicornCorporateFollow38.4k followers OverviewRubicon Research Pvt. Ltd. is an emerging pharmaceutical company, focused on developing value added products for the pharmaceutical industry as well as developing their portfolio of generic prescription and OTC products covering a broad range of therapeutic categories. The company is a preferred partner for the industry in the development of specialized oral solid, oral liquid and topical dosage forms. Rubicon has 13 approvals in the orange book, one filed NDA and more than 20 filed ANDA’s from their manufacturing facility. The Company operates out of three locations, the R&D center based in Thane, India; USFDA/MHRA compliant manufacturing facility based out of Ambernath, India and a marketing office based out of Princeton, New Jersey. In Jul 2018; Rubicon Research Pvt. Ltd. (Rubicon), has opened its new 38,000-sq.-ft. laboratory and corporate office in Thane, Maharashtra. This new facility provides the company with an independent facility, close to Mumbai allowing for continued growth and a more efficient workspace for its 200+ employees at this location. The new state-of-the-art R&D center is built to GMP standards and will complement Rubicon’s demonstrated expertise in formulation product development and analytical method development with the latest infrastructure and efficient design. The R&D center will now equip Rubicon to carry out complete: • Oral Solid Dosage form development from pre-formulation studies upto pilot scale in a single facility • Oral liquid dosage form development suite upto pilot scale • Topical dosage form development suite upto pilot scale • Sterile dosage form development including injectable and ophthalmic dosages • Dedicated containment suite for development of highly potent products including hormonal products and oncology products read moreWhy Join Us?At Rubicon, we are driven by the purpose of delivering meaningful healthcare solutions that improve lives globally. Through innovation in drug delivery technologies and a focus on complex formulation challenges, we empower employees to make a tangible impact in advancing patient care. As a part of this dynamic, IP-led pharmaceutical organization, every employee contributes to developing differentiated products and services for both the regulated and emerging markets, while continuously enhancing their skills and expertise. read moreCompany InfoLink:Rubicon Research websiteBeware of imposters! Naukri.com does not promise a job or an interview in exchange of money. Fraudsters may ask you to pay in the pretext of registration fee, Refundable Fee…Read moreRubicon Research rolesyou might be interested inProcurement-Intern0-1 YrsThane, Navi Mumbai, Mumbai (All Areas)Posted 30+ Days AgoAssistant Account Manager3-8 YrsMumbai, Thane, Navi MumbaiPosted 10 Days AgoManager Finance4-9 YrsMumbai Suburban, Thane, Navi MumbaiPosted 21 Days AgoReviewsView all417 employee reviews5.0rated by Senior Executive in ThaneRubicon's culture, growth opportunities gives feel good experience. Rubicon always provides opportunity for Learning, growth, explore new things-Challenges for self Evolve. Its a fastest growing organization, which always asked you to be on toe always, with speed.Read full reviewPowered bySalary insightsExecutive in Rubicon Research typically earns between₹8.2 - ₹9.1 L/yrSee detailed salary breakupPowered byBenefits & PerksView all30 employees reported these benefitsHealth & Wellness SupportTransport / Travel SupportLearning & Development SupportFree MealPerformance BonusPowered by

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