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Research Assoc I

7.00 to 10.00 Years   Ahmedabad   07 Jun, 2022
Baxter India
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    Research Assoc IApply Now Save JobThis is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.
    • To devise, upgrade & implement quality systems for Research and Development (R&D).
    • To prepare and review Standard Operating Procedure for implementation of quality systems in R&D and ensure compliance to GQPs and local procedures.
    • To design formats for data recording in F&D, ADL, RA and Characterization team to capture data in right manner.
    • To review, approve and ensure Technology Transfer Dossier (TDD) from F&D and ADL to respective plant.
    • To monitor proper transfer of documents from F&D, ADL, RA to respective plant.
    • To initiate, assess, review and approve change controls, NCR/SNCR, Laboratory Investigation Report (LIR), CAPA, Effectiveness checks, etc.
    • To coordinate functionalities and streamline working of different software s like compliance builder, Open Lab, BAXU, ELN, Track wise 8, TcU, Controlled format system etc. and ensure compliance to the same. To be trained on the updated versions of the software and impart awareness across different R&D functions.
    • To audit R&D laboratory for data integrity and 21 CFR compliance.
    • To support Sub-department Manger to face external audits.
    • To carry out internal quality audits of F&D, ADL labs & RA from compliance & upgradation point of view in line with GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice).
    • To ensure that F&D and ADL follows required practices for stability studies, including data capturing of stability chambers.
    • To verify Validation and Calibration Master schedule and ensure compliance for internal and external calibration and validation status of equipment.
    • To monitor and enhance entry and exit procedures & gowning practices followed in R&D laboratory.
    • To review online data recording periodically in Electronic Lab Notebook (ELN) for the experiment carried out in F&D & ADL labs.
    • To ensure that the development is carried out as per latest QBD (Quality by Design) and PDLM concepts.
    • To assist Sub-department Manager to impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices.
    • To review F&D documents like MFR (Master Formula Record), PDR (Pharma Development Report), study protocols, stability protocols, PDLM documents, SOPs, calibration schedules, instrument qualification protocol and reports for adequacy and accuracy.
    • To review ADL documents like specifications, MOA, Method transfer protocol and report, method validation protocol and report, method verification protocol and report, stability sheets, SOPs, calibration schedules, instrument qualification protocol and reports etc. and give approval.
    ,

Keyskills :
standard operating procedurequality auditinternal quality auditordata integrity21 cfrgmp good manufacturing practiceglp good laboratory practice

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