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Lead - Developmental and Reproductive Toxicology (DART)

9.00 to 12.00 Years   Delhi   09 May, 2023
Syngene International Limited
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    • Overall adherence to safe practices and procedures of oneself and the teams aligned
    • Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards
    • Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
    • Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
    • Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
    • Compliance to Syngene s quality standards at all times
    Core Purpose of the Role: As a Study Director Developmental and Reproductive Toxicology (DART):
    • Responsible for ensuring that GLP toxicology studies; developmental and reproductive toxicity studies are carried out to the required scientific and regulatory standards as per Global regulatory guidelines [ICH/OECD].
    • Function as single point of study control, overall responsibility for the scientific, technical, and regulatory conduct of studies, scientific interpretation, documentation and reporting of results.
    • Attending client meetings, reviewing business proposals for DART studies
    • Working as a SME in DART domain, managing and training team members
    Role Accountabilities
    • Preparation of study plan considering the client requirements as well as regulatory requirements.
    • Preparing a study schedule and communicating with all the study personnel and ensuring the proper conduct of the study.
    • Preparing reports after completion of each study. This involves evaluating the data output by applying scientific knowledge and skills.
    • To maintain the highest regulatory standards (GLP and AAALAC recommendations) during any activity conducted in the facility by continuous monitoring and checkup of all the instruments/equipment used in a study as per Standard Operating Procedures (SOPs).
    • Preparation and periodic revision of Standard Operating Procedures.
    • Preparation and presentation of experiment conduct protocols to the Institutional Animal Ethics committee.
    • Periodically verify data generated during study.
    • Archival of the study plan, study report, raw data and related materials as per the study plan.
    • Coordinate with Principal Investigators and/or study personnel in case of multi-site studies keeping informed of their findings during the study and receipt and evaluation of their respective individual reports for inclusion in the final study report.
    Syngene Values All employees will consistently demonstrate alignment with our core values
    • Excellence
    • Integrity
    • Professionalism
    Specific requirements for this role
    1. Experience
    2. Demonstrated Capability
    3. Education
    Experience
    • 9-12 years
    Skills and Capabilities 1. Good understanding and hands on Experience of toxicology. Preferably have knowledge of related disciplines, toxicokinetics, pathology and analytical chemistry. 2. Candidate working in or have relevant experience in contract research organization will be preferred. Education MSc Additional Qualification M.V.Sc., M.Pharm, PhD ,

Keyskills :
standard operating proceduresquality standardsclient requirements

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