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apply now Mgr, R&D - ADL

4.00 to 6.00 Years   Ahmedabad   27 Sep, 2022
Baxter India
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaR&D / Product Design
EmploymentTypeFull-time

Job Description

    Mgr, R&D - ADLApply 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.
    • Overall responsibility of Analytical Method Transfer from ADL R&D to Baxter s and non-Baxter s domestic and overseas manufacturing/QC unit and contract testing laboratories (at present more than 11 sites/labs) for new and existing products which includes API, FP in close coordination with F&D, PQ, RA and PMO
    • To review the weekly and monthly plan to ensure smooth method transfer in coordination with CMOs
    • To ensure the availability of necessary resources or instruments to carry out the method transfer at CMOs
    • Play a lead role in resolution of the challenges faced during Analytical method transfer of new products from R&D to Manufacturing site.
    • Overall responsibility of analytical method evaluation, development, and validation for residual solvents in API and preservatives, their impurities in FP by Gas Chromatography
    • API source evaluation from Gas Chromatography perspective
    • Overall responsibility of leading documentation cell to support R&D and RA for specs, MoA for API, FP, excipients, and packaging material
    • Responsible for setting up a GLP group within ADL department in coordination with other analytical leads to increase lab compliance, ensure completion of preventive maintenance, internal and external calibration, AMC/CMC etc.
    • To plan and allocate work or project to team members to ensure the timely delivery of projects.
    • Overall responsible for LIR, CAPA, NCR closure from GLP, GC, Method transfer aspect
    • Responsible for preparation, review and approval of URS and SSJ, procurement of new instruments through CAPEX in close coordination with procurement and project
    • To ensure compliance/mitigation of HAZID, E&C, Data integrity, training & GLP in ADL department
    • To plan Microbiological testing, DMF review and sorting out queries from Baxter and Non-Baxter quality labs from microbiology aspect (MLT, BET, Sterility, Bio-burden tests etc.) to support NPD
    • To ensure Pharmacopeial updation in timely manner in R&
    Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to hidden_email and let us know the nature of your request along with your contact information.Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .079520Apply Now Save Job,

Keyskills :
mail sortingpreventive maintenancemethod transferdata integrity

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