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Senior Research Associate

0.00 to 3.00 Years   Kolkata   24 Sep, 2022
Syngene International Limited
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Responsible for pre-formulation and formulation development, stability studies, scale-up and GMP manufacturing of drug product based on the scope of projects. Key Responsibilities:
    • Has hands-on working experience on different solid oral manufacturing equipment (not limited) like RMG, fluid bed top spray granulation, roller compactor, powder blenders, tablet compression machines, Wurster processors, tablet coating machines, capsule filling machines, spray dryer and hot melt extruders.
    • Should have understanding of QBD.
    • Should have understanding of data integrity.
    • Plan the project activities as per strategies based on literature and IP evaluation.
    • Has developed products for ANDA/EU/China filing.
    • Has basic understanding on the USFDA, ICH and EMEA guidelines for filing for drug products.
    • Responsible for execution and recording of development trial batches and execution of GMP batches under the supervision of senior scientists in the team.
    • Executes technical activities involving active pharmaceutical ingredients that may be potent or hazardous while following appropriate safety procedures.
    • Works independently, supervised on a weekly basis, recognizes key issues likely to affect successful and/or timely completion.
    • Communication and coordination with cross functional team for project related activities.
    • Plan and execute project activities.
    • Coordinate with vendors for API and RM procurement.
    • For those issues that cannot be resolved by the project team, brings them to the attention of the line manager.
    • Compilation and interpretation of experiment results and PPT preparation.
    • Completes development reports and regulatory support documentation as required.
    • Has basic understanding on MFR and MPR preparation and BMR and BPR review.
    • Maintains an awareness of current scientific practice and current good manufacturing processes
    • When requested, provides other support as required.
    • Complies with Health, Safety and Environmental responsibilities for the position.
    • Maintains current training records for required procedures.
    • Complies with departmental and company quality and safety policies.
    • Understanding of niche technology such as nano-dispersion, lipid based drug delivery system, SMEDDS, amorphous formulation would be beneficial
    • Having basic knowledge on 505b2 would be beneficial.
    • Having basis knowledge on scale up parameter calculation would be beneficial.
    • Additional work experience on parenteral and topical products is also beneficial.
    • Communication with client for projects would be beneficial.
    Educational Qualification & Experience: M Pharma with 0-3 years of experience ,

Keyskills :
continuous improvement facilitationvalidationliteratureactive pharmaceutical ingredientsresearchnmr

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