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Research Scientist - BBRC

9.00 to 11.00 Years   Kolkata   14 Dec, 2022
Syngene International Limited
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaR&D / Product Design
EmploymentTypeFull-time

Job Description

    Key Responsibilities:
    • Routine testing of stability samples using chromatographic, dissolution, and wet analytical techniques under a GMP environment following all cGMP practices
    • Performing instrument calibration, method validation, and method transfers
    • Interpretation of stability data and results trending
    • Investigation of OOS/OOT and other laboratory events
    • Preparing the Standard Operating Procedure
    • Preparing stability summary reports and review of final documents
    • Compliance & implementation of quality systems
    • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
    • Responsible for the activities assigned within the team
    • Deliver analytical results within the established windows and as per applicable guidelines
    • Escalation of issues / non-conformity with applicable procedures/policies
    • Electronic lab notebook documentation
    • Troubleshooting HPLC and dissolution apparatus
    • Miscellaneous lab responsibilities
    Educational Qualifications: M.Sc. Chemistry or M. Pharm 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, method validation, and routine analysis
    • 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 must
    Experience: 12-15 years with M.Sc. or 9-11 years with M. Pharm for 7-I 15-17 years with M.Sc. or 12-15 years with M.Pharm for 7-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.
    • Ability to meet tight deadlines and prioritize workloads.
    ,

Keyskills :
researchhplcchemistryvalidationapiresearchdevelopment

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