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Senior Executive

6.00 to 9.00 Years   Navi Mumbai   06 Jan, 2022
Job LocationNavi Mumbai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Designation: Senior Executive, Biopharmaceutical OperationsJob Location: Bengaluru, IndiaReporting to: Assisstant Manager, Biopharmaceutical OperationsJob Grade: 9Operating Unit : BiopharmaceuticalDepartment: Biopharmaceutical OperationsThe CompanySyngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.The RolePurpose 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.Key Result AreasRole-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.ScExperience6-9 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
Equal Opportunity EmployerIt is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.Please visit us at https://syngeneintl.com/ to know more about us and what we do.,

Keyskills :
customer servicemanufacturing processequipment qualificationsalesunit operationsquality standardsdata managementmiscontinuous improvement facilitationconsumer goodsmanagement systemsanimal healthdeliverycustomer relationsequal employment opp

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