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Associate Scientist - Sample_Custodian

6.00 to 8.00 Years   Chennai, Hyderabad, Kolkata   16 Aug, 2022
Syngene International Limited
Job LocationChennai, Hyderabad, Kolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Job Purpose: The position holder is responsible for Sample Receipt, Accessioning, Registration and compliance.Key Responsibilities:
    1. Effective and Strategic Planning for sample handling
    2. Preparation of sample receipt and sample handling related documents
    3. Ensure all the e-manifests are getting imported in Watson LIMS within 10 working days (from the day of receipt without samples discrepancies) by SD. If sample discrepancies identified the same should be follow up with SD until resolution.
    4. Register all the receipt samples once import is getting completed by SD.
    5. Deliver Quality data within agreed timelines by working closely with SD. Document contemporaneously of all sample receipt documents, logbooks appropriately for completeness.
    6. Temperature monitoring by chart recorder and daily review and verification of electronic temperature monitoring. Recording, filing and archival and printout of all temperature observations.
    7. Ensure training of the SOPs, MOA and study plan before participating any study activities.
    8. Timely and effective communication and interaction with SD. Timely communication of samples study files and submission of complete samples study documents with SD.
    9. Ensure sample reconciliation process are regular and update is available
    10. Provide support in E-Formatter software for E-manifest; resolve manifest query with SD, Provide Watson LIMS support for sample query
    11. Provide support to CSV team (Computerized System validation) performance and review of qualification documents.
    12. Creation of project, study folders and access management in ELN (Electronic Laboratory Notebook)
    13. Provide support to Facility related work whenever required
    Educational Qualification: Master s degree in Biological Sciences (Preferably Biochemistry background) or a related field.Technical/functional Skills: Good knowledge of MS Office applications is necessary Handling audits and participation in audits is preferable Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines.Experience:6 - 8 yearsBehavioral Skills:Should be independent.Excellent communication skills - written and oral in EnglishShould have good interpersonal skillsLarge degree of flexibility and ability to work under strong time pressure,

Keyskills :
21 cfrhplcprotocolsvalidationdocumentationms office

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