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Executive 1

3.00 to 6.00 Years   Delhi   26 May, 2023
Sygene
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaExecutive Assistant (EA)
EmploymentTypeFull-time

Job Description

    Purpose of this role is responsible to execute fundamental unit operations in Upstream manufacturing related to the manufacturing of bulk drug substance in the Microbial facility.Role-specific:
    • Execution of fundamental tasks CIP,SIP of Manufacturing process Equipments, media, buffer preparation vessels and close monitoring of batch performance data.
    • Planning of Raw materials/consumables management for Manufacturing Campaign.
    • Coordination with Cross functional departments for the activities like preventive, breakdown, maintenance, sample submission ,raw material & consumables readiness ,closure of documentation.
    • Documents work according to cGMP and cGDP, adhere to established regulations and follows cGMP established by site.
    • Reports abnormalities and deviations in timely and accurate manner, maintain facility areas according to predefined standards like SOPs,EOPs, Contribute to investigations and area Walk-throughs.
    • Adheres to Syngene safety standards and identifies unsafe situations/habits and escalates appropriately.
    • Perform Upstream activities under limited supervision and according to standard operating and manufacturing procedures.
    Education and ExperienceEducationM.ScExperience3-6 yearsFunctional or Technical skills Required
    • Expertise in upstream Unit operations (E.coli & Yeast), hands on experience in microbial process at manufacturing scale through automated SS fermenters and associated controls.
    • Exposure to handle Bio-similar proteins handling in cGMP area, sound knowledge and awareness of GMP controls, Quality standards and regulatory aspects.
    • Good in Quality Management systems & risk assessment tools.
    • Experience in Equipment Qualification and commission aspects
    ,

Keyskills :
consumer goodsdata managementfinacleclearingrisk assessmentanimal healthcustomer service

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