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Research Associate - ARD-SBL

1.00 to 2.00 Years   Delhi   02 May, 2023
Syngene International Limited
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    Research Associate (9-I) or Senior Research Associate (9-II) Analytical Research and Development working on Analytical GMP testing (AGT), and Syngene BMS Laboratory (SBL) stability programs
    • Testing of samples (drug substance and drug product for release testing and stability) using chromatographic, dissolution, and wet analytical techniques under a GMP environment following cGMP practices
    • Analysis of API clinical campaign samples manufactured in Syngene pilot plant
    • Qualification or requalification of API reference standards.
    • Performing instrument calibration and qualification
    • Performing method validation, and method transfers
    • Troubleshooting HPLC, dissolution apparatus and other analytical instruments in the lab
    • Deliver analytical results within the established windows and as per applicable guidelines
    • Compliance & implementation of quality systems
    • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
    • Electronic lab notebook documentation
    • Miscellaneous lab responsibilities
    Educational Qualifications: M.Sc. Chemistry for 9-I; M.Sc. Chemistry or M. Pharm for 9-II; Technical/Functional Skills:
    • The candidate should have a good educational and theoretical, analytical chemistry background
    • Good knowledge of analytical techniques
    • The candidate should understand instrument calibration, qualification, method validation, and analytical testing
    • Good understanding of documentation as per GxP requirements (electronic notebook)
    • The candidate should have good proficiency in MS office tools
    • Experience in stability samples testing and good knowledge of ICH guidelines & cGMP regulatory requirements
    • Must have worked in a cGMP-regulated environment, exposure to regulatory inspections like US FDA, MHRA, etc. is preferred.
    Experience: 1-2 years with M.Sc. for 9-I ; 3-5 years with M.Sc. or 1-2 years with M. Pharm for 9-II Behavioral Skills:
    • Strong commitment toward work and a high level of dedication, enthusiasm, and motivation
    • Good speaking-listening-writing skills, attention to detail, proactive self-starter
    • Ability to work successfully in a dynamic environment
    • Should be able to work in a team and flexible for working in shifts.
    ,

Keyskills :
validationhplcdocumentationresearchdevelopmentanalytical chemistry

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